Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Female Infertility

Treatments: Drug: Progesterone; Drug: gonadotropin releasing hormone-agonist

Study type: Interventional

Funder types: Other

Identifiers

NCT05286554

0201599

Details and patient eligibility

About

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Enrollment: 75 patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient age ≤ 38 years.
2. BMI ≤ 30.
3. Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.
4. Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.

Exclusion criteria

1. Endometriosis.
2. Polycystic ovarian syndrome (PCOS).
3. Uterine pathology or anomaly.
4. Evidence of hydrosalpinx by hysterosalpingography or ultrasound.
5. Comorbidities: Diabetes mellitus, hypertension, immune diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Group 1

Experimental group

Description:

Will receive routine LPS and additional single GnRH-a bolus, triptorelin 0.1 mg subcutaneous injection on the 6th day after oocyte retrieval.

Treatment:

Drug: gonadotropin releasing hormone-agonist

Drug: Progesterone

Group 2

Experimental group

Description:

Will receive routine LPS and additional multiple mid-luteal GnRH-a, triptorelin 0.1 mg subcutaneous injection on the 5th, 7th and 9th days after oocyte retrieval.

Treatment:

Drug: gonadotropin releasing hormone-agonist

Drug: Progesterone

Group 3 (Control)

Active Comparator group

Description:

Will receive the routine LPS without GnRH-a

Treatment:

Drug: Progesterone