Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)

NCTNCT00697255 (opens ClinicalTrials.gov in a new tab)Other idP05693Other id2006-000705-30Other id107010Other idMK-8962-002
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
8 participants (actual)
Sponsor
Organon and Co · Industry
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
15 May 2007
Primary completion
3 Apr 2008
Completion
15 May 2008
First posted
13 Jun 2008 (estimated)
Last update posted
17 Jun 2024
Conditions
Ovulation Induction

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009
  1. Ph 2

    A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)

    NCT00697255

    15 May 2007 to 15 May 2008

    Terminated

Registry summary

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

The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or recombinant Follicular Stimulating Hormone (recFSH) can induce monofollicular growth (one follicle ≥18 mm and no other follicle ≥15 mm at day of bolus injection of hCG) in women with WHO group II anovulatory infertility.

Interventions

  • corifollitropin alfaDrug
  • recombinant Follicle Stimulating Hormone (recFSH)Biological
  • human Chorion Gonadotropin (hCG)Biological
  • hCG Bolus injectionBiological

Arms2

  • Experimental

    corifollitropin alfa + recFSH

    Eligible participants will receive a subcutaneous (SC) injection of corifollitropin alfa (Stage 1a: 15mcg, Stage Ib/II: 30 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient, the participant will receive a second or third dose of corifollitropin alfa (Stage 1a: 15 mcg, Stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm, the participant will start daily SC injections with FSH (Stage 1A: 50 IU, Stage II: 75 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed.

  • Experimental

    corifollitropin alfa + hCG

    Eligible participants will receive a SC injection of corifollitropin alfa (Stage Ia:15 mcg, Stage Ib/II: 30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth is insufficient the participant will receive a second or third dose of corifollitropin alfa (Stage IA: 15 mcg, stage Ib/II: 20 mcg). As soon as the largest follicle reaches a size of ≥12 mm the participant will start daily SC injections with hCG (Stage Ib/II: 200 IU) the same day. A bolus injection of hCG (5000 IU) will be administered if at least one follicle is ≥18 mm and in total no more than two follicles ≥15 mm are observed.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Monofollicular Response (Monofollicular Rate)

    Time frame · At day of bolus injection of hCG (up to 20 days)

    Registry description

    The monofollicular rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) divided by the number of the treated participants.

Secondary outcomes(5)

  1. Percentage of Participants With Ovulation (Ovulation Rate)

    Time frame · 8 days after bolus injection of hCG (up to 28 days)

    Registry description

    Ovulation rate was defined as the number of participants with confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.

  2. Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)

    Time frame · 8 days after bolus injection of hCG (up to 28 days)

    Registry description

    Monofollicular ovulation rate was defined as the number of participants with monofollicular response (one follicle ≥18 mm and no other follicle ≥15 mm on the day of the bolus injection of hCG) and confirmed ovulation (≥15 nmol/l serum progesterone eight days after the bolus injection of hCG) divided by the number of treated participants. Ovulation was also considered confirmed for participants who became pregnant, had an ectopic pregnancy or had a miscarriage.

  3. Percentage of Participants Who Cancelled Treatment (Cancellation Rate)

    Time frame · Up to 3 weeks after bolus injection of hCG (up to 41 days)

    Registry description

    Treatment was considered cancelled if no bolus injection of hCG was administrated. Reasons of treatment failure included Adverse Event (AE)/ Serious Adverse Event (SAE), insufficient ovarian response on stimulation day 13 (no follicle ≥12 mm), insufficient ovarian response after 7 days of hCG/recFSH treatment (no follicle ≥18 mm), and multifollicular growth (≥3 follicles ≥15 mm).

  4. Number of Participants With Pregnancy

    Time frame · At least 10 weeks after bolus injection of hCG (up to 13 weeks)

    Registry description

    A pregnancy test (serum or urinary hCG) was performed two to three weeks after bolus injection of hCG. In case of a positive pregnancy test vaginal and/or abdominal ultrasound scan was performed to confirm the pregnancy at 5 to 6 weeks after bolus injection of hCG and ≥10 weeks after bolus injection of hCG to confirm ongoing pregnancy.

  5. Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)

    Time frame · During In-Treatment Period (up to 14 weeks after first corifollitropin injection)

    Registry description

    OHSS was classified on study based on a slightly modified WHO Scientific Group (1973) classification: Grade I (mild) = characterized by excessive steroid secretion and ovarian enlargement (5-7 cm). Abdominal discomfort, including abdominal pain, is present. Grade II (moderate) = characterized by distinct ovarian cysts (ovary size 8-10 cm), accompanied by abdominal pain and tension, nausea, vomiting, diarrhea. Grade III (severe) = characterized by enlarged cystic ovaries (ovary size \>10 cm), accompanied by ascites and occasionally hydrothorax. Abdominal tension and pain may be severe. Pronounced hydrothorax together with an abdominal cavity filled with cysts and fluid elevating the diaphragm may cause severe breathing difficulties. Large quantities of fluid inside the cysts and in the peritoneal and pleural cavities cause haemoconcentration and increased blood viscosity. In rare cases, the syndrome may further be complicated by the occurrence of thromboembolic phenomena.

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· At day of bolus injection of hCG (up to 20 days)

Percentage of Participants With Monofollicular Response (Monofollicular Rate)

GroupValue (percentage of participants)
Corifollitropin Alfa + recFSH0
Corifollitropin Alfa + hCG0
Secondary and other outcome results(5)
Secondary outcomeNumber· 8 days after bolus injection of hCG (up to 28 days)

Percentage of Participants With Ovulation (Ovulation Rate)

GroupValue (percentage of participants)
Corifollitropin Alfa + recFSH40.0
Corifollitropin Alfa + hCG33.3
Secondary outcomeNumber· 8 days after bolus injection of hCG (up to 28 days)

Percentage of Participants With Monofollicular Ovulation (Monofollicular Ovulation Rate)

GroupValue (percentage of participants)
Corifollitropin Alfa + recFSH0
Corifollitropin Alfa + hCG0
Secondary outcomeNumber· Up to 3 weeks after bolus injection of hCG (up to 41 days)

Percentage of Participants Who Cancelled Treatment (Cancellation Rate)

GroupValue (percentage of participants)
Corifollitropin Alfa + recFSH20.0
Corifollitropin Alfa + hCG33.3
Secondary outcomeNumber· At least 10 weeks after bolus injection of hCG (up to 13 weeks)

Number of Participants With Pregnancy

GroupValue (participants)
Corifollitropin Alfa + recFSH0
Corifollitropin Alfa + hCG1
Secondary outcomeNumber· During In-Treatment Period (up to 14 weeks after first corifollitropin injection)

Number of Participants With AEs of Ovarian Hyperstimulation Syndrome (OHSS)

GroupValue (participants)
Corifollitropin Alfa + recFSH0
Corifollitropin Alfa + hCG0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Corifollitropin Alfa + recFSHEligible participants in Stage 1a received a subcutaneous (SC) injection of corifollitropin alfa (15 mcg) the first, second, or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient, the participant received a second or third dose of corifollitropin alfa (15 mcg). As soon as the largest follicle reached a size of ≥12 mm, the participant started daily SC injections with recFSH (50 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.–0 / 52 / 5
Corifollitropin Alfa + hCGEligible participants in Stage 1b received a SC injection of corifollitropin alfa (30 mcg) the first, second or third day after onset of a progestagen-induced withdrawal bleeding. If the follicle growth was insufficient the participant received a second or third dose of corifollitropin alfa (20 mcg). As soon as the largest follicle reached a size of ≥12 mm the participant started daily SC injections with hCG (200 IU) the same day. A bolus injection of hCG (5000 IU) was administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed.–0 / 32 / 3

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 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Oligomenorrhea (average cycle length ≥35 days and \<6 months) * Amenorrhea (average cycle length ≥6 months) * Body Mass Index ≥18 and ≤30 kg/m\^2 * Normal serum FSH levels and normal estradiol levels at screening * Progestagen induced withdrawal bleeding * Age ≥18 years and ≤39 years at the time of signing informed consent * Willing and able to sign informed consent Exclusion Criteria: * History of or current ovarian cysts or enlarged ovaries not related to polycystic ovarian syndrome (PCOS) * History of or current tumors of the ovary, breast, uterus, pituitary or hypothalamus * Less than 2 ovaries * Undiagnosed vaginal bleeding * Any ovarian and/or abdominal abnormality interfering with ultrasound examination * Malformations of the sexual organs incompatible with pregnancy * Pregnancy or lactation * Abnormal serum endocrinology levels based on screening sample * Any clinically relevant abnormal laboratory value based on screening sample * Alcohol or drug abuse within the 12 months preceding signing of informed consent * Hypersensitivity to any of the substances in corifollitropin alfa * Hypersensitivity to hCG/ Puregon® or any of its components * Previous use of corifollitropin alfa * Use of any investigational drug during 90 days before screening

PepBank is a research reference. Talk to a doctor before you use any peptide.