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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00702338
First received: June 18, 2008
Last updated: May 14, 2014
Last verified: May 2014

June 18, 2008
May 14, 2014
May 2008
August 2008   (final data collection date for primary outcome measure)
  • Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Protocol Defined [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year) ] [ Designated as safety issue: No ]
    The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants treated in base study P05693.
  • Percentage of Mothers With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate): Alternate Analysis [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to time of birth on current follow-up study (up to 1 year) ] [ Designated as safety issue: No ]
    Take-Home Baby Rate was alternately defined ad hoc as the number of participants with an ongoing pregnancy in base study P05693 (NCT00697255) with at least one live born infant in the current follow-up study divided by the total number of participants who received bolus injection of hCG in the base study.
  • Number of Mothers With Adverse Events (AEs) During Follow-up [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year) ] [ Designated as safety issue: Yes ]
    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
  • Number of Mothers With Serious AEs (SAEs) During Follow-up [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 1 day after birth on current follow-up study (up to 1 year) ] [ Designated as safety issue: Yes ]
    An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
  • Number of Infants With AEs During Follow-up [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study ] [ Designated as safety issue: Yes ]
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
  • Number of Infants With SAEs During Follow-up [ Time Frame: From ≥10 weeks after bolus injection of hCG (administered in study P05693) up to 12 weeks after birth on current follow-up study ] [ Designated as safety issue: Yes ]
    An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Prenatal diagnosis; Mode of delivery; Neonatal outcome; Safety assessment subjects/mothers and newborns/infants; Major/minor congenital malformations [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00702338 on ClinicalTrials.gov Archive Site
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Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05693 (P05713)
Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Ovulation Induction in Clinical Trial 107010 for the Development of Org 36286 (Corifollitropin Alfa)

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.

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).

Observational
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Women with an ongoing pregnancy at least 10 weeks after bolus injection of hCG in base study P05693 (NCT00697255).

  • Pregnancy
  • Neonates
  • Drug: 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.
    Other Names:
    • Org 36286
    • MK-8962
    • SCH 900962
  • Biological: 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.
  • 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.
  • 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.
  • 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).
    Interventions:
    • Drug: corifollitropin alfa
    • Biological: recombinant Follicle Stimulating Hormone (recFSH)
    • Biological: hCG Bolus injection
  • 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).
    Interventions:
    • Drug: corifollitropin alfa
    • Biological: human Chorion Gonadotropin (hCG)
    • Biological: hCG Bolus injection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
December 2008
August 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 39 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00702338
P05713, 2006-000967-26, 107011, MK-8962-006
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP