Stop Menstruation and Pregnancy Rates in Antagonist Protocol

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357473
• Other study ID #: 239
• Status: Completed
• Phase: N/A
• First received: May 9, 2011
• Last updated: May 19, 2011
• Start date: November 2009
• Est. completion date: May 2011

Study information

• Verified date: May 2011
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 2011
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate.		3 months	Yes