Estrogen Pretreatment Prior to GnRH Antagonist Protocol

Gemer

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: 17beta-estradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT01489852

E2PRETREATMENT

Details and patient eligibility

About

The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.

Enrollment: 472 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• regular normo-ovulatory cycles (28 to 35 days)
• age < 38 years,
• body mass index (BMI) between 18 and 30
• first or second IVF/ICSI attempt

Exclusion criteria

• high basal levels of serum FSH or E2,
• less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
• history of high (>20 oocytes) or low (< 5 oocytes) ovarian response in a previous IVF attempt

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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472 participants in 2 patient groups

Estrogen pre-treatment

Active Comparator group

Treatment:

Drug: 17beta-estradiol

Control

No Intervention group

Description:

The control group did not receive any pre-treatment.