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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

Low-dose Gonal-f® in Ovulation Induction

Short name LoGo

NCTNCT01871532 (opens ClinicalTrials.gov in a new tab)Other idEMR700623_535Other id2012-003227-38

This trial does not test a peptide that PepBank tracks.

  • Measures hCG (human chorionic gonadotropin), does not give it. It appears in an outcome measure.

Overview

Status
Terminated
Phase
Phase 4
Enrollment
24 participants (actual)
Sponsor
Merck KGaA, Darmstadt, Germany · Industry
Design
Randomized · Open label (no masking)
Countries
2 countries

Ireland, United Kingdom

Start
Jul 2013
Primary completion
Mar 2014
Completion
Nov 2014
First posted
6 Jun 2013 (estimated)
Last update posted
11 Aug 2016 (estimated)
Conditions
Infertility · Monofollicular Development

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015
  1. Ph 4

    LoGo

    NCT01871532

    Jul 2013 to Nov 2014

    Terminated

Registry summary

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

This is a prospective, multicenter, open-label, comparative and parallel-group study of ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH) treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2 anovulatory subjects who have previously failed to conceive with clomifene treatment.

Interventions

  • Gonal-f®Drug

Arms2

  • Experimental

    Low Dose Gonal-f® Protocol

    Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

  • Active comparator

    Standard Low Dose Gonal-f® Protocol

    Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Cycles With Monofollicular Development

    Time frame · Baseline up to 4 weeks

    Registry description

    The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle Greater Than or Equal (\>= to 17 millimeter (mm) and no other follicles Greater than or equal to 14 mm following up to 4 weeks Gonal-f treatment.

Secondary outcomes(14)
  1. Percentage of Cycles With Bifollicular Development

    Time frame · Baseline up to 4 weeks

    Registry description

    The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.

  2. Percentage of Cycles With Multifollicular Development

    Time frame · Baseline up to 4 weeks

    Registry description

    The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles greater than or equal to 14 millimeter

  3. Percentage of Ovulatory Cycles

    Time frame · Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration

    Registry description

    Ovulation was defined as a serum progesterone (P4 ) level greater than or equal to 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.

  4. Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered

    Time frame · Baseline up to 4 weeks

  5. Percentage of Cycles Resulting in Clinical Pregnancy

    Time frame · 35-42 days post hCG administration

    Registry description

    Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.

  6. Number of Multiple Pregnancy

    Time frame · 35-42 days post hCG administration

    Registry description

    Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning-identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.

  7. Number of Fetuses

    Time frame · 35-42 days post hCG administration

  8. Number of Miscarriages After Confirmation of Clinical Pregnancy

    Time frame · 35-42 days post hCG administration

    Registry description

    Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.

  9. Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)

    Time frame · up to 42 days post hCG administration

    Registry description

    OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.

  10. Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation

    Time frame · Baseline up to 4 weeks

  11. Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle

    Time frame · Baseline up to 4 weeks

  12. Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4

    Time frame · Baseline, Week 4

  13. Testosterone Levels

    Time frame · Baseline

  14. Sex Hormone Binding Globulin (SHBG) Levels

    Time frame · Baseline

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 outcome· Baseline up to 4 weeks

Percentage of Cycles With Monofollicular Development

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary and other outcome results(7)
Secondary outcome· Baseline up to 4 weeks

Percentage of Cycles With Bifollicular Development

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary outcome· Baseline up to 4 weeks

Percentage of Cycles With Multifollicular Development

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary outcome· Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration

Percentage of Ovulatory Cycles

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary outcome· Baseline up to 4 weeks

Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary outcome· 35-42 days post hCG administration

Percentage of Cycles Resulting in Clinical Pregnancy

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary outcome· 35-42 days post hCG administration

Number of Multiple Pregnancy

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted
Secondary outcome· 35-42 days post hCG administration

Number of Fetuses

GroupValue
Low Dose Gonal-fnot posted
Standard Low Dose Gonal-fnot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Low Dose Gonal-fGonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.–0 / 122 / 12
Standard Low Dose Gonal-fGonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.–1 / 123 / 12

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 37 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Subjects eligible for ovulation induction treatment, where monofollicular development is the desired treatment outcome and the dose schedule outlined in the protocol is deemed appropriate * Premenopausal female subjects, aged between 18 and 37 years inclusive * Subjects desirous of pregnancy/willing to conceive * Subjects who are infertile due to chronic anovulation demonstrated by cycle duration of greater than 35 days. * Subjects who have been treated with clomifene citrate therapy, according to standard site practice, and have failed to ovulate and/or conceive * Subjects with follicle stimulating hormone (FSH) and prolactin (PRL) serum values within the normal range in the early follicular phase * Subjects with an overall total antral follicle count greater than 10 (of follicle size greater than or equal to 2 millimeter \[mm\] and less than 11 mm) (that is, total between both ovaries) * Subjects with at least one patent tube, as documented by recent (within 2 years before treatment assignment) hysterosalpingography (HSG) or hysterosalpingo contrast sonography (HyCoSy) * Subjects with normal uterine cavity, as documented by recent (within 2 years before treatment assignment) hysteroscopy, HSG or ultrasound scan * Subjects with body mass index (BMI) greater than 20 and less than or equal to 32 kilogram per square meter (kg/m\^2) (BMI is equal to body weight \[kilogram {kg}\] divided by Height \* Height \[square meter {m\^2}\]) * Subjects with negative cervical Papanicolaou (PAP) test conducted according to national guidelines and/or standard site practice * Male partners of female subjects with sperm compatible with non-assisted fertilization or availability of donor sperm, as confirmed by the Investigator * Subjects who are willing and able to comply with protocol requirements and have provided written, informed consent Exclusion Criteria: * Subjects with history of hypersensitivity to the investigational medicinal product (IMP) (active substance follitropin alpha, FSH, or to any of the excipients of Gonal-f®) or any other drug used in the trial (that is, Ovitrelle) * Subjects with ovarian enlargement or ovarian cyst unrelated to Polycystic Ovary Syndrome (PCOS), and of unknown origin on ultrasound * Subjects with evidence of diminished ovarian reserve (cycle length less than 26 days; FSH above the upper limit of local serum FSH values, total antral follicle count \[AFC\] in both ovaries less than 10) * Subjects with uterine pathology/abnormalities, which in the opinion of the Investigator could impair pregnancy evolution * Subjects who have undergone three or more previous miscarriages * Subjects with any previous extrauterine pregnancy * Pregnant or lactating female subjects * Subjects with abnormal gynecological bleeding of unknown etiology. * Subjects with previous history of severe ovarian hyper stimulation syndrome (OHSS) (after clomifene treatment) * Subjects who have evidence of current or previous pelvic inflammatory disease before treatment assignment * Subjects with tumors of the hypothalamus and pituitary gland * Subjects with ovarian, uterine or mammary carcinoma * Subjects treated with clomifene citrate or gonadotropins within 1 month of the screening evaluation * Subjects with any medical condition which, in the opinion of the Investigator, would prevent an effective response, such as primary ovarian failure, or malformations of the reproductive organs incompatible with pregnancy * Subjects with any medical condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug * Subjects with any clinically significant systemic disease (for example, insulin-dependent diabetes) or any contraindication to being pregnant and/or carrying a pregnancy to term * An active substance abuser * Known infection with human immunodeficiency virus (HIV), Hepatitis B or C virus in the trial subject or her male partner * Subjects who are currently participating in another clinical trial * Subjects who are unable to give written informed consent

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