Stop Menstruation and Pregnancy Rates in Antagonist Protocol

This study has been completed.
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01357473
First received: May 9, 2011
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

The proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH- antagonist cycles.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Hormonal Exposure of Endometrium on the First Day After Menstruation Associated With the Probability of Pregnancy in Patients Treated With Rec-FSH/ GnRH Antagonist? A Prospective Trial

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • Ongoing pregnancy rate. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: November 2009
Study Completion Date: May 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Ovarian stimulation will be achieved by rec- FSH, Puregon® starting on day 2 of the cycle at a dose of 200 IU/day. The dose of rec-FSH remains unchanged during stimulation until day 10 of the cycle. If it is necessary to increase the dose of rec-FSH after 10 days of stimulation, or to decrease the dose of rec-FSH due to a risk of OHSS, the patient will be dropped out of the study.

To inhibit premature LH surge daily GnRH - antagonist (orgalutran 0,25mg ) is used from the morning of day 6 of stimulation.

Final oocyte maturation will be achieved by administration of 10.000 IU of HCG (Pregnyl®) as soon as ≥ 3 follicles ≥ 17 mm are present. E2 levels should not be criteria for HCG administration. Oocyte retrieval will be carried out 36 hours after HCG administration. Conventional IVF or ICSI will be carried out. Embryo transfer will be carried out day3 or day5 after oocyte retrieval.

Similar luteal support for all patients with vaginal administration of 600mg natural micronised progesterone in three separate doses (Utrogestan® 200mg 3xday) starting one day after oocyte retrieval will be used. Hormonal assessment (E2,FSH,LH,Progesterone) will be performed at initiation of stimulation, on the first day after the period had stopped and every 2 days until the day of HCG administration.

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Infertility women treated with rec FSH/antagonist protocol

Criteria

Inclusion Criteria:- Age ≤ 39 years

  • Body mass index between 18 and 29 kg/m²¬
  • Regular cycles between 25-34 days
  • Presence of both ovaries
  • Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
  • Treatment with IVF/ICSI
  • Embryo transfer day 3 or day 5 (1 or 2 embryos)
  • Patients can enter in the study only once

Exclusion Criteria:

  • Presence of endometriosis stage ≥3(AFS)
  • Polycystic ovarian syndrome (Rotterdam criteria)
  • Need for preimplantation genetic diagnosis (PGD)
  • Azoospermia testicular sperm extraction (TESE)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357473

Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
Principal Investigator: DIMITRA KYROU, MD CRG UZ BRUSSEL
  More Information

No publications provided

Responsible Party: DEVROEY PAUL, CRG UZ BRUSSEL
ClinicalTrials.gov Identifier: NCT01357473     History of Changes
Other Study ID Numbers: 239
Study First Received: May 9, 2011
Last Updated: May 19, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
hormonal values
menstruations
pregnancy
antagonist

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 16, 2014