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NCT00724789·Not applicable·OBSERVATIONAL

Monitor the Incidence of Congenital Malformations in Infants of Women Who Have Been Treated With Ganirelix (Orgalutran®)(Study 38644)(P05966)(COMPLETED)

GanirelixOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

2,066

Locations

0

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The primary purpose of this study is to collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian stimulation with recombinant follicle stimulating hormone /ganirelix followed by in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (ICSI), and to compare this incidence with that of a group of women who used a long protocol with a gonadotropin releasing hormone agonist as historical controls.

Interventions

Treatment arms and agents.

DRUG

ganirelix

Daily 0.25 mg ganirelix administered to prevent premature LH surges during COS in order to achieve a pregnancy

DRUG

GnRH agonist

Long protocol of GnRH agonist administered to prevent premature LH surges during COS in order to achieve a pregnancy

Timeline

From registration to results.

  1. First posted

    Jul 30, 2008

  2. Study start

    Nov 2000

  3. Primary completion

    Nov 2005

  4. Study completion

    Nov 2005

  5. Results posted

    Not reported

  6. Registry updated

    Feb 3, 2022

Outcomes

What the study measures.

Primary outcomes

To collect data on the incidence of congenital malformations in infants of women with an ongoing pregnancy after controlled ovarian hyperstimulation.

Time frame · In both cohorts a follow-up pediatric evaluation was scheduled within 6 months post-partum

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
39 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * Puregon® (recFSH)/Orgalutran® group: * Women with a pregnancy of \>= 16 weeks after Puregon® /Orgalutran® treatment for IVF or ICSI and ET of fresh embryos. Treatment is defined as having had at least one injection of Orgalutran®. * Women between 18 and 39 years of age (inclusive) at the day of hCG. * Women who are able and willing to sign informed consent. Controls * Infants (gestational age \>=16 weeks) of women pregnant after COH using a GnRH agonist in a long protocol for IVF or ICSI and ET of fresh embryos. * Infants of women between 18 and 39 years of age (inclusive) at the day of hCG. * The most recent 1000 infants delivered prior to January 1, 2001. Exclusion Criteria: * None

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

PMID 20378616 ↗Bonduelle M, Oberye J, Mannaerts B, Devroey P. Large prospective, pregnancy and infant follow-up trial assures the health of 1000 fetuses conceived after treatment with the GnRH antagonist ganirelix during controlled ovarian stimulation. Hum Reprod. 2010 Jun;25(6):1433-40. doi: 10.1093/humrep/deq072. Epub 2010 Apr 8.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsGanirelix trial dashboard →DatabaseGanirelix database entry →ResearchGanirelix research guide →