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OpenTrials
Completed

NCT Number: NCT00750100

Low Dose hCG in the Late Follicular Phase

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UZ Brussel

Laarbeeklaan 101, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • < 36 years on day of randomisation
  • FSH < 12 in the early follicular phase
  • Normal ultrasound scan
  • BMI between 18 and 29 (both inclusive)
  • Randomisation at outpatient clinic

Exclusion criteria

  • Endometriosis ≥ grade 3
  • PCO syndrome
  • Poor responder
  • Endocrine or metabolic abnormalities

Treatment and study plan

Human Chorionic Gonadotropin

Drug

hCG 200IU in the late follicular phase

Other names: Pregnyl, NV Organon, Oss, The Netherlands

recombinant gonadotropins

Drug

200 IU per day during controlled ovarian stimulation

Other names: Puregon, NV Organon, Oss, The Netherlands

Primary outcomes

  1. Number of oocytes in both treatment groups

    Time frame: up to 9 months

Secondary outcomes

  1. Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group

    Time frame: up to 9 months

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Among ICSI Patients Undergoing Antagonist Protocols With Recombinant FSH, Does Replacement of Recombinant FSH by 200 IU of hCG in the Late Follicular Phase Compared With Continuing Recombinant FSH, Result in a Similar Number of Oocytes?

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2008
Registry last updated
Oct 11, 2010

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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