Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment

University of Sao Paulo

Status and phase: Unknown; Phase 3

Conditions: Infertility

Treatments: Drug: GnRH agonist; Drug: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT00948805

0555/09

Details and patient eligibility

About

This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

Full description

The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

Enrollment: 25 estimated patients

Sex: Female

Ages: 21 to 38 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age >21 and < 38 years old
• polycystic ovarian syndrome
• risk for ovarian hyperstimulation syndrome

Exclusion criteria

• recurrent abortion
• endometriosis
• more than 3 IVF failures
• use of oral contraceptive pills in the preceding 3 months
• low response to gonadotropins

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 2 patient groups

GnRH agonist

Experimental group

Description:

3,6 mg of goserelin acetate (GnRH agonist) will be administered on the 21st day of the menstrual cycle previous to ovarian stimulation. 250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

Treatment:

Drug: GnRH agonist

Control

Active Comparator group

Description:

250 mg of hCG will be administered on the first day of menses and a starting dose of 150 IU of FSH will be started 2 days later as a part of a long ovarian stimulation protocol. Ovulation will be triggered with a 250 mg of hCG when at least 2 follicles attain 18mm and to accommodate oocyte retrieval within 36 hours.

Treatment:

Drug: Control