Percentage of Cycles With Monofollicular Development
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataShort name LoGo
This trial was stopped early.
Reason given at the registry: Study was terminated because of delays in sourcing replacement Investigational Medicinal Product for the study due to manufacturing delays.
Results were posted for this trial.
This trial does not test a peptide that PepBank tracks.
Ireland, United Kingdom
1 trial · 1 stopped early · 1 with posted results
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.
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.
Outcomes the sponsor listed as primary.
Percentage of Cycles With Monofollicular Development
Time frame · Baseline up to 4 weeks
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.
Percentage of Cycles With Bifollicular Development
Time frame · Baseline up to 4 weeks
The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 millimeter.
Percentage of Cycles With Multifollicular Development
Time frame · Baseline up to 4 weeks
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
Percentage of Ovulatory Cycles
Time frame · Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration
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.
Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) Was Not Administered
Time frame · Baseline up to 4 weeks
Percentage of Cycles Resulting in Clinical Pregnancy
Time frame · 35-42 days post hCG administration
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.
Number of Multiple Pregnancy
Time frame · 35-42 days post hCG administration
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.
Number of Fetuses
Time frame · 35-42 days post hCG administration
Number of Miscarriages After Confirmation of Clinical Pregnancy
Time frame · 35-42 days post hCG administration
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.
Number of Subjects With Ovarian Hyper Stimulation Syndrome (OHSS)
Time frame · up to 42 days post hCG administration
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.
Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation
Time frame · Baseline up to 4 weeks
Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered Per Cycle
Time frame · Baseline up to 4 weeks
Change From Baseline in Anti-Mullerian Hormone (AMH) Levels at Week 4
Time frame · Baseline, Week 4
Testosterone Levels
Time frame · Baseline
Sex Hormone Binding Globulin (SHBG) Levels
Time frame · Baseline
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Value |
|---|---|
| Low Dose Gonal-f | not posted |
| Standard Low Dose Gonal-f | not posted |
| Group | Deaths | Serious events | Other 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 / 12 | 2 / 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 / 12 | 3 / 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
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