Duration of GnRH-analogue Downregulation and Pregnancy Rates

Aristotle University Of Thessaloniki

Status and phase: Terminated; Phase 4

Conditions: Infertility

Treatments: Procedure: Duration of GnRH agonist downregulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00436319

UHR-2

Details and patient eligibility

About

The purpose of this study is to assess whether the probability of pregnancy is dependent on the duration of GnRH agonist downregulation in IVF cycles.

Full description

GnRH agonists have been used extensively in assisted reproduction technologies for inhibition of gonadotropin secretion from the pituitary prior to initiation of ovarian stimulation. Administration of GnRH agonists results in the prevention of spontaneous LH surges, which lead to luteinization of the developing follicles, initiation of final oocyte maturation and a decrease in pregnancy rates.

GnRH agonists are usually administered according to two protocols: the short and long protocol.In the long protocol, downregulation with GnRH agonists is initiated either in the middle of the secretory phase, or at the beginning of the follicular phase. Stimulation of the ovaries with gonadotropins is initiated when downregulation is confirmed.

Administration of gonadotropins is usually started during the second or third week of treatment with GnRH agonists.The possibility of earlier initiation of the ovarian stimulation, if downregulation is confirmed at an earlier stage, has not been examined so far.

The purpose of this study is to assess whether the duration of pituitary downregulation with GnRH agonists, prior to initiation of ovarian stimulation with gonadotropins, has any effect on pregnancy rate, in women undergoing IVF.

Enrollment: 300 patients

Sex: Female

Ages: 19 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age under 39
• less than 3 previous IVF cycles
• BMI 18-29
• normal ultrasound of internal genital organs

Exclusion criteria

• polycystic ovarian syndrome
• endometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

1

No Intervention group

Description:

In the control group (group 1) the initiation of the ovarian stimulation will be realized according to the typical long luteal protocol, two weeks after the initiation of the GnRH agonist administration.

2

Other group

Description:

In the study group (group 2) the initiation of the ovarian stimulation will be effectuated on the second day of the menstrual period.

Treatment:

Procedure: Duration of GnRH agonist downregulation