Trial · Interventional

CompletedPhase 4Results postedRegistry data

MENOPUR® Versus FOLLISTIM®

NCTNCT00802360Other id2008-04

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 173 participants (actual)
Sponsor: Ferring Pharmaceuticals · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Dec 2008
Primary completion: Nov 2009
Completion: Jan 2010
First posted: 4 Dec 2008 (estimated)
Last update posted: 2 Nov 2011 (estimated)
Conditions: Infertility

Timeline

1 trial · 1 completed · 1 with posted results

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

2008200920102011

Ph 4
MENOPUR® Versus FOLLISTIM®
NCT00802360
Dec 2008 to Jan 2010

Registry summary

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

To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles

Interventions

MenotropinDrug
Progestrone vaginal insertDrug
follitropin betaDrug
Progesterone in oilDrug
GanirelixDrug

Arms4

Experimental
Menopur/Endometrin
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. Progestrone vaginal insert (Endometrin®) 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
Menopur/Progesterone in Oil
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 in Oil 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
Follistim/Endometrin
Follitropin 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. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Active comparator
Follistim/Progesterone in Oil
Follitropin 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 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.

Percentage of Participants With Ongoing Pregnancy at Week 8
Time frame · Week 8 (Week 6 of gestation)
Registry description
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.

Secondary outcomes(10)

Number of Follicles Observed at Day 15
Time frame · 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 within 34-36 hours of human chorionic gonadotropin (hCG) administration.
Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
Time frame · Approximately Day 19
Registry description
The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.
Number of Embryos Transferred at Three Stages of Development
Time frame · Approximately Day 24
Registry description
The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.
Number of Embryos Frozen at Day 24
Time frame · Approximately Day 24
Registry description
The number of embryos that were not transferred but instead were frozen for future use.
Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
Time frame · Day 1 to Day 24
Registry description
A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Participants With Biochemical Pregnancy at 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.
Participants With Clinical Pregnancy at Week 7
Time frame · approximately week 7
Registry description
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Time frame · Day 1 - week 12
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.
Number of Live Births
Time frame · Approximately 10 months

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· Week 8 (Week 6 of gestation)

Percentage of Participants With Ongoing Pregnancy at Week 8

Group	Value (percentage of participants)
Menopur/Endometrin	45.2
Menopur/Progesterone in Oil	45.2
Follistim/Endometrin	42.9
Follistim/Progesterone in Oil	48.7

Secondary and other outcome results(7)

Secondary outcomeMean· Day 15

Number of Follicles Observed at Day 15

Group	Value (follicles)	Spread
Menopur	15.6	8.6
Follistim	16.2	8.4

Secondary outcomeMean· Approximately Day 18

Number of Oocytes Retrieved at Day 18

Group	Value (oocytes)	Spread
Menopur	11.5	6.3
Follistim	13.8	7.9

Secondary outcomeMean· Approximately Day 19

Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved

Group	Value (proportion of oocytes retrieved)	Spread
Menopur	0.3	0.4
Follistim	0.3	0.4

Secondary outcomeMean· Approximately Day 24

Number of Embryos Transferred at Three Stages of Development

Group	Value (embryos)	Spread
Menopur	2.1	0.7
Follistim	2.4	0.7

Secondary outcomeMean· Approximately Day 24

Number of Embryos Frozen at Day 24

Group	Value (embryos)	Spread
Menopur	1.9	2.9
Follistim	1.6	2.5

Secondary outcomeNumber· Day 1 to Day 24

Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle

Group	Value (participants)
Menopur/Endometrin	0
Menopur/Progesterone in Oil	1
Follistim/Endometrin	1
Follistim/Progesterone in Oil	2

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

Participants With Biochemical Pregnancy at Day 38

Group	Value (participants)
Menopur/Endometrin	21
Menopur/Progesterone in Oil	20
Follistim/Endometrin	22
Follistim/Progesterone in Oil	23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Menopur/EndometrinHighly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day 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 inserted vaginally 2 or 3 times daily (BID or TID) 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 / 42	20 / 42
Menopur/Progesterone in OilHighly purified menotropin 225 IU by subcutaneous injection once per day 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 injections 50 mg by intramuscular injection (IM) once per day 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 / 42	18 / 42
Follistim/EndometrinFollitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day 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 inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.	–	1 / 42	18 / 42
Follistim/Progesterone in OilFollitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day 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 injections 50 mg by intramuscular injection (IM) once per day 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 / 39	21 / 39

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.

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. Body mass index (BMI) of 18-34 3. Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) \<15 IU/L and Estradiol (E2) within normal limits 4. 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.) 5. Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa 6. Signed informed consent Exclusion Criteria: 1. Gestational or surrogate carrier, donor oocyte 2. Presence of any clinically relevant systemic disease (e.g., 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. Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of \>2 previous failed in vitro fertilization (IVF) cycles. 5. History of recurrent pregnancy loss (\>2). 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 \[TESE\])

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