Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)

NCT ID: NCT00702338

Last Updated: 2024-09-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-15
• Study Completion Date: 2008-12-15

Brief Summary

The objective of follow-up study P05713 is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of monofollicular growth in women who underwent ovulation induction (OI) in base study P05693 (NCT00697255) is safe for pregnant participants and their offspring.

Detailed Description

Base study P05693 (NCT00697255) was planned to include two separate stages (Ia+Ib and II).

Stage Ia was open-label and uncontrolled in a small cohort of women (n=5) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose recombinant Follicle Stimulating Hormone (recFSH) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage Ib was open-label and uncontrolled in a small cohort of women (n=3) to explore whether the intended dosing regimen of corifollitropin alfa followed by daily low dose Human Chorion Gonadotropin (hCG) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

Stage II was planned to be open-label and randomized (n=40) to evaluate whether the intended dosing regimen of corifollitropin alfa followed by low dose recFSH (n=20) or hCG (n=20) would provide an appropriate response in eligible participants meeting all inclusion and none of the exclusion criteria.

P05713 is a follow-up (FU) study to prospectively monitor pregnancy, delivery, and neonatal outcome of women who became ongoing pregnant during base study P05693 (NCT00697255). For this trial, no study specific assessments will be required and no treatment will be administered, but information as obtained in standard practice will be used. Enrollment will begin when the first ongoing pregnancy resulting from the base study has been established (ultrasound ≥ 10 weeks after bolus injection of hCG).

Conditions

Pregnancy; Neonates

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

corifollitropin alfa + recFSH Mothers

Eligible participants in Stage 1a of base study P05693 (NCT00697255) were administered injection(s) with subcutaneous (SC) corifollitropin alfa (15mcg) and daily SC injections with recFSH (50 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then to be followed for safety and efficacy on the current follow-up (FU) study (P05713) according to standard practice (no treatment administered).

corifollitropin alfa

Intervention Type: DRUG

SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

recombinant Follicle Stimulating Hormone (recFSH)

Intervention Type: BIOLOGICAL

Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

hCG Bolus injection

Intervention Type: BIOLOGICAL

Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.

corifollitropin alfa + hCG Mothers

Eligible participants in Stage 1b of base study P05693 (NCT00697255) were administered injection(s) with SC corifollitropin alfa (30 mcg) and daily SC injections with hCG (200 IU) when the largest follicle reached a size of ≥12 mm. A bolus injection of hCG (5000 IU) was then administered if at least one follicle was ≥18 mm and in total no more than two follicles ≥15 mm were observed. Eligible mothers in this group with an ongoing pregnancy established in the base study (confirmed at ≥10 weeks after hCG bolus injection) were then followed for safety and efficacy on the current FU study (P05713) according to standard practice (no treatment administered).

corifollitropin alfa

Intervention Type: DRUG

SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

human Chorion Gonadotropin (hCG)

Intervention Type: BIOLOGICAL

Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

hCG Bolus injection

Intervention Type: BIOLOGICAL

Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.

Interventions

corifollitropin alfa

SC injection(s) of corifollitropin alfa (30 mcg) was administered the first, second or third day after onset of progestagen-induced withdrawal bleeding in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

Intervention Type: DRUG

recombinant Follicle Stimulating Hormone (recFSH)

Daily injections of SC recFSH (50 IU/75 IU) were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

Intervention Type: BIOLOGICAL

human Chorion Gonadotropin (hCG)

Daily injections of SC hCG injection were administered as soon as the largest follicle reached a size ≥ 12 mm 4 days after a corifollitropin alfa injection (on stimulation day 5, 9 or 13) in base study P05693 (NCT00697255). No treatment was administered on the current follow-up study.

Intervention Type: BIOLOGICAL

hCG Bolus injection

Bolus injection of SC hCG was administered in base study P05693 (NCT00697255) to induce final oocyte maturation if at least one follicle was ≥18 mm and no more than two follicles ≥15 mm were observed. No treatment was administered on the current follow-up study.

Intervention Type: BIOLOGICAL

Other Intervention Names

Org 36286; MK-8962; SCH 900962

Eligibility Criteria

Inclusion Criteria

• Participants who participated in base study P05693 (NCT00697255) and received at least one dose of corifollitropin alfa
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after bolus injection of hCG in base study P05693
• Able and willing to give written informed consent (informed consent is

incorporated in the informed consent form of protocol P05693)

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Bonduelle M, Mannaerts B, Leader A, Bergh C, Passier D, Devroey P. Prospective follow-up of 838 fetuses conceived after ovarian stimulation with corifollitropin alfa: comparative and overall neonatal outcome. Hum Reprod. 2012 Jul;27(7):2177-85. doi: 10.1093/humrep/des156. Epub 2012 May 15.

Reference Type: DERIVED

PMID: 22587997 (View on PubMed)

Other Identifiers

2006-000967-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

107011

Identifier Type: OTHER

Identifier Source: secondary_id

MK-8962-006

Identifier Type: OTHER

Identifier Source: secondary_id

P05713

Identifier Type: -

Identifier Source: org_study_id