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Completed

NCT Number: NCT00702624

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05690 (Care Program) (P05710)

The objective of this follow-up study is to evaluate whether corifollitropin alfa (Org 36286) treatment for the induction of multifollicular growth in women undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) is safe for pregnant participants and their offspring.

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Key information

Conditions

Pregnancy Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neonates

Age range

18 year–36 year

Sex eligibility

Female

Study type

Observational

About this study

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcome of women who were treated with corifollitropin alfa or recFSH and became pregnant during the base study P05690 (NCT00702845). For this trial no study specific assessments are required, but information as obtained in standard practice will be used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who participated in base study P05690 (NCT00702845) and received at least one dose of either corifollitropin alfa (Org 36286) or recFSH in base study P05690;
  • Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in base study P05690;
  • Able and willing to give written informed consent.

Exclusion criteria

  • None

Treatment and study plan

Corifollitropin alfa

Drug

Single injection of 100 μg corifollitropin alfa administered under protocol P05690

Other names: SCH 900962, MK-8962

recFSH (follitropin beta)

Biological

Daily recFSH administered under protocol P05690

Other names: follitropin beta, Puregon®, Follistim®

gonadatropin releasing hormone (GnRH) antagonist ganirelix

Drug

GnRH antagonist ganirelix administered SC at a dose of 0.25 mg/day under protocol P05690

human Chorion Gonadotropin (hCG)

Biological

hCG 5,000 IU/USP or 10,000 IU/USP administered under protocol P05690

progesterone

Biological

Under protocol P05690, progesterone was started on the day of oocyte pick-up (OPU) and continued for at least 6 weeks or up to menses. Participants received at least 600 mg/day vaginally or 50 mg/day IM.

placebo-recFSH (follitropin beta)

Drug

Placebo-recFSH at the equivalent volume of 150 IU/day administered under protocol P05690

placebo-corifollitropin alfa

Drug

Single SC injection of placebo-corifollitropin alfa on Day 2 or 3 of the menstrual cycle, administered under protocol P05690

open-label recFSH (follitropin beta)

Biological

Open-label recFSH up to a maximum dose of 200 IU/day, administered under protocol P05690

Primary outcomes

  1. Percentage of Women With ≥1 Live Born Infant During Follow-up (Take-Home Baby Rate)

    Time frame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

    The Take-Home Baby Rate was defined as the number of participants with an ongoing pregnancy in base study P05690 with at least one live born infant during follow up relative to the number of participants treated in base study.

  2. Number of Expectant Mothers Experiencing Adverse Events (AEs)

    Time frame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

    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.

  3. Number of Expectant Mothers Experiencing Serious AEs (SAEs)

    Time frame: From approximately 10 weeks after ET in base study P05690 up to birth of infant (up to approximately 6 months)

    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.

  4. Number of Infants Experiencing AEs

    Time frame: Up to 12 weeks after birth

    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 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.

  5. Number of Infants Experiencing SAEs

    Time frame: Up to 12 weeks after birth

    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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 107012 for the Development of Org 36286 (Corifollitropin Alfa)

Acronym: Care

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 20, 2008
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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