Trial · Interventional

CompletedPhase 4Results postedRegistry data

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

NCTNCT00805935Other id2008-05

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 110 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Jan 2009
Primary completion: Jul 2010
Completion: Sept 2010
First posted: 10 Dec 2008 (estimated)
Last update posted: 27 Jan 2012 (estimated)
Conditions: Polycystic Ovarian Syndrome · Infertility

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 4
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
NCT00805935
Jan 2009 to Sept 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

Interventions

MenotropinDrug
Progesterone vaginal insertDrug
Follitropin betaDrug
Progesterone in oilDrug
leuprolide acetateDrug

Arms4

Experimental
Menotropin/Progesterone vaginal insert
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Experimental
Menotropin/Progesterone in oil
Menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Active comparator
Follitropin beta/Progesterone vaginal insert
Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Active comparator
Follitropin beta/Progesterone in oil
Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Primary outcomes1

Outcomes the sponsor listed as primary.

Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3
Time frame · weeks 1-3
Registry description
A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).

Secondary outcomes(13)

Number of Follicles Observed at Day 15
Time frame · approximately day 15
Registry description
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
Number of Oocytes Retrieved at Day 18
Time frame · approximately day 18
Registry description
The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.
Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved
Time frame · approximately day 19
Registry description
The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.
Number of Embryos Transferred at Three Stages of Development Before Implantation
Time frame · approximately day 24
Registry description
The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells. Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.
Number of Embryos Frozen
Time frame · approximately day 24
Registry description
The number of embryos that were not transferred but instead were frozen for future use.
Percentage of Participants With Biochemical Pregnancy at Approximately Day 38
Time frame · approximately day 38 (Day 14 post embryo transfer)
Registry description
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
Percentage of Participants With Clinical Pregnancy at Week 7
Time frame · approximately Day 52
Registry description
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Percentage of Participants With Ongoing Pregnancy at Week 9
Time frame · approximately Day 65
Registry description
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Estradiol Levels at Day 6
Time frame · Day 6
Registry description
Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.
Human Chorionic Gonadotropin (hCG) Levels at Day 6
Time frame · Day 6
Registry description
Blood tests were sent to a central laboratory to obtain hCG levels.
Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration
Time frame · approximately day 16
Registry description
Blood tests were sent to a central laboratory to obtain progesterone levels.
Number of Live Births Resulting From the In Vitro Fertilization Process
Time frame · Approximately 10 months
Registry description
Number of live births resulting from the IVF process
Participants With Treatment Emergent Adverse Events
Time frame · Week 1 to week12
Registry description
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· weeks 1-3

Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3

Group	Value (Participants)
Menotropin/Progesterone Vaginal Insert	1
Menotropin/Progesterone in Oil	0
Follitropin Beta/Progesterone Vaginal Insert	1
Follitropin Beta/Progesterone in Oil	0

Secondary and other outcome results(7)

Secondary outcomeMean· approximately day 15

Number of Follicles Observed at Day 15

Group	Value (Follicles)	Spread
Menotropin	27.7	12.8
Follitropin Beta	30.5	16.1

Secondary outcomeMean· approximately day 18

Number of Oocytes Retrieved at Day 18

Group	Value (Oocytes)	Spread
Menotropin	13.0	7.7
Follitropin Beta	15.6	8.6

Secondary outcomeNumber· approximately day 19

Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved

Group	Value (Percentage of oocytes retrieved)
Menotropin	17.1
Follitropin Beta	24.8

Secondary outcomeMean· approximately day 24

Number of Embryos Transferred at Three Stages of Development Before Implantation

Group	Value (Embryos)	Spread
Menotropin	2.0	0.7
Follitropin Beta	2.0	0.5

Secondary outcomeMean· approximately day 24

Number of Embryos Frozen

Group	Value (Embryos)	Spread
Menotropin	1.9	2.3
Follitropin Beta	1.9	2.6

Secondary outcomeNumber· approximately day 38 (Day 14 post embryo transfer)

Percentage of Participants With Biochemical Pregnancy at Approximately Day 38

Group	Value (Percentage of participants)
Menotropin/Progesterone Vaginal Insert	60.0
Menotropin/Progesterone in Oil	55.6
Follitropin Beta/Progesterone Vaginal Insert	60.7
Follitropin Beta/Progesterone in Oil	73.3

Secondary outcomeNumber· approximately Day 52

Percentage of Participants With Clinical Pregnancy at Week 7

Group	Value (Percentage of participants)
Menotropin/Progesterone Vaginal Insert	56.0
Menotropin/Progesterone in Oil	33.3
Follitropin Beta/Progesterone Vaginal Insert	46.4
Follitropin Beta/Progesterone in Oil	66.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Menotropin/Progesterone Vaginal InsertHighly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.	–	0 / 25	9 / 25
Menotropin/Progesterone in OilHighly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.	–	1 / 27	11 / 27
Follitropin Beta/Progesterone Vaginal InsertFollitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.	–	0 / 28	15 / 28
Follitropin Beta/Progesterone in OilFollitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.	–	0 / 30	14 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedBeltsos AN, Sanchez MD, Doody KJ, Bush MR, Domar AD, Collins MG. Patients' administration preferences: progesterone vaginal insert (Endometrin(R)) compared to intramuscular progesterone for Luteal phase support. Reprod Health. 2014 Nov 11;11:78. doi: 10.1186/1742-4755-11-78. PMID 25385669

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 42 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Pre-menopausal females between the ages of 18 and 42 years 2. Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies \[congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome\]) * Oligo- or anovulation * Clinical and/or biochemical signs of hyperandrogenism * Polycystic ovaries 3. Body mass index (BMI) of 18-39 4. Early follicular phase (Day 3) follicle stimulating hormone (FSH) \< 15 IU/L and estradiol (E2) within normal limits 5. Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women \> 38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.) 6. Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa 7. Signed informed consent Exclusion Criteria: 1. Gestational or surrogate carrier, donor oocyte 2. Presence of any clinically relevant systemic disease (e.g., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, uterine cancer) 3. Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used 4. Two or more previous failed in vitro fertilization (IVF) cycles or in vitro fertilization (IVF)/assisted reproductive technology (ART) failure due to a poor response to gonadotropins, defined as development of 2 mature follicles 5. History of recurrent pregnancy loss, defined as more than two clinical losses 6. Presence of abnormal uterine bleeding of undetermined origin 7. Current or recent substance abuse, including alcohol or smoking \> 10 cigarettes per day 8. Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests 9. Participation in any experimental drug study within 30 days prior to Screening 10. Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration \[MESA\], testicular sperm extraction \[TESE\]) 11. Prior hypersensitivity to any of the protocol drugs

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