Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial 38833 (P05783) (Care)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The objective of this trial is to evaluate whether corifollitropin alfa (MK-8962, 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.

Condition or disease	Intervention/treatment
Pregnancy; Neonates	Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug; Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug; Drug: Triptorelin; Biological: Recombinant follicle stimulating hormone (recFSH); Biological: Human chorionic gonadotprophin (hCG).

Detailed Description:

This is a follow-up protocol to prospectively monitor pregnancy, delivery, and neonatal outcomes of all women who were treated with corifollitropin alfa and became pregnant during the base Trial 38833. For this follow-up trial (38834), no investigational products will be administered and no study specific assessments are required, but information will be obtained as per standard clinical practice.

Study Design

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Study Type :	Observational
Actual Enrollment :	15 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established After Controlled Ovarian Stimulation in Clinical Trial 38833 for Org 36286 (Corifollitropin Alfa)
Actual Study Start Date :	April 1, 2006
Actual Primary Completion Date :	November 7, 2007
Actual Study Completion Date :	January 15, 2008

Groups and Cohorts

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Group/Cohort	Intervention/treatment
Corifollitropin alpha 100 ug; In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily subcutaneous (SC) injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous luteinizing hormone (LH) and follicle stimulating hormone (FSH) was confirmed by estradiol (E2) and progesterone (P) measurements, a single dose of corifollitropin alpha 100 μg was administered in participants weighing <= 60 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recombinant follicle stimulating hormone (recFSH) injections (maximally 200 IU) up to and including the day of administration of human chorionic gonadotprophin (hCG). No study medications were administered in the present P05783 study (38834, NCT00702520).	Drug: Corifollitropin alpha (MK-8962, Org 36286) 100 ug; Subcutaneous administration of corifollitropin alpha at a dose of 100 ug Drug: Triptorelin; Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). Biological: Recombinant follicle stimulating hormone (recFSH); From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. Biological: Human chorionic gonadotprophin (hCG).; HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.
Corifollitropin alpha 150 ug; In the base study (P05788, 38833, NCT00702351), participants were pre-treated with daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). After suppression of endogenous LH and FSH was confirmed by E2 and P measurements, a single dose of corifollitropin alpha 150 μg was administered in participants weighing >= 50 kg. From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. No study medications were administered in the present P05783 study (38834, NCT00702520).	Drug: Corifollitropin alpha (MK-8962, Org 36286) 150 ug; Subcutaneous administration of corifollitropin alpha at a dose of 150 ug Drug: Triptorelin; Daily SC injections of 0.1 mg triptorelin started between Day 21 and 24 of the menstrual cycle (mid luteal phase). Biological: Recombinant follicle stimulating hormone (recFSH); From stimulation Day 8 onwards, treatment was continued with daily SC of recFSH injections (maximally 200 IU) up to and including the day of administration of hCG. Biological: Human chorionic gonadotprophin (hCG).; HCG was administered as a single subcutaneous injection of 5,000 to 10,000 international units.

Outcome Measures

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Primary Outcome Measures :

1. Number of Expectant Mothers Experiencing Adverse Events (AEs) [ Time Frame: Up to 1 Year ]
   An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
2. Number of Expectant Mothers Experiencing Serious AEs (SAEs) [ Time Frame: Up to 1 Year ]
   An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
3. Number of Infants Experiencing AEs [ Time Frame: Up to 1 Year ]
   An AE is any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with study drug administration whether or not considered related to the use of the study drug.
4. Number of Infants Experiencing SAEs [ Time Frame: Up to 1 Year ]
   An AE or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
5. Take-Home Baby Rate [ Time Frame: Birth of a one or more live babies (Up to 1 year) ]
   The take-home baby rate was calculated as the number of participants with a least one live born infant in the follow-up study (P05783, 38834, NCT00702520) relative to the number of participants treated with Corifollitropin alpha in the base study (P05788, 38833, NCT00702351).

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 39 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women with an ongoing pregnancy at least 10 weeks after embryo transfer in Trial 38833 were enrolled in this trial.

Criteria

Inclusion Criteria:

• Participants who received one dose of corifollitropin alfa in Trial 38833;
• Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in Trial 38833;
• Able and willing to give written informed consent.

Exclusion Criteria:

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Data/Documents: CSR Synopsis 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00702520 History of Changes
Other Study ID Numbers:	P05783; 38834 ( Other Identifier: Organon ); MK-8962-010 ( Other Identifier: Merck ); 2005-000062-40 ( EudraCT Number )
First Posted:	June 20, 2008
Results First Posted:	June 20, 2014
Last Update Posted:	April 18, 2017
Last Verified:	March 2017

Keywords provided by Merck Sharp & Dohme Corp.:

Neonatal outcome; Congenital malformations; In-Vitro fertilization; Controlled ovarian stimulation; Follow-up

Additional relevant MeSH terms:

Hormones; Follicle Stimulating Hormone; Triptorelin Pamoate; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Luteolytic Agents	Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents