Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

Summary

Gonadotropin Releasing Hormone agonist (GnRHa) triggering is used as an alternative to human chorionic gonadotropin (hCG) in GnRH antagonist protocol to eliminate the risk of ovarian hyperstimulation syndrome (OHSS). However, its main disadvantage is a significantly lower pregnancy rate, hypothesized to result from a process called "luteolysis" (demise of the corpora lutea). In order to preserve a high pregnancy rates, several luteal support regimens were investigated, including an intensive estrogen and progesterone supplementation and a daily GnRHa treatment. However, no study, so far, compared the efficacy of these two regimens. Our aim is to compare the efficacy of GnRHa versus estrogen and progesterone supplementation for luteal phase support in high responders following GnRHa triggering.

Conditions

• Pregnancy Early
• Miscarriage
• Ovarian Hyperstimulation Syndrome

Interventions

DRUG

Synarel, 0.2 Mg/Inh Nasal Spray

Intranasal treatment with Nafarelin inhaler: 200 micrograms twice daily (a total of 400 micrograms/d; Synarel, Pfizer) on the evening after oocyte retrieval, which will be continued up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be stopped.

DRUG

Estrofem

A combination of oral estrogen (Estrofem or Progynova 4 mg twice daily), vaginal progesterone (vaginal Utrogestan 200mg or Endometrin 100 mg three times daily) and intramuscular injection of Hydroxyprogesterone Caproate 250 mg once every five days. The treatment will start at the day of the oocyte retrieval up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be continued up to 9+0 weeks of pregnancy.

DRUG

Utrogestan

A combination of oral estrogen (Estrofem or Progynova 4 mg twice daily), vaginal progesterone (vaginal Utrogestan 200mg or Endometrin 100 mg three times daily) and intramuscular injection of Hydroxyprogesterone Caproate 250 mg once every five days. The treatment will start at the day of the oocyte retrieval up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be continued up to 9+0 weeks of pregnancy.

DRUG

Hydroxyprogesterone Caproate

A combination of oral estrogen (Estrofem or Progynova 4 mg twice daily), vaginal progesterone (vaginal Utrogestan 200mg or Endometrin 100 mg three times daily) and intramuscular injection of Hydroxyprogesterone Caproate 250 mg once every five days. The treatment will start at the day of the oocyte retrieval up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be continued up to 9+0 weeks of pregnancy.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center

  lead OTHER_GOV

Principal Investigators

• Michal Youngster, MD · Assaf-Harofeh Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-29

Primary Completion

2021-09-30

Completion

2021-09-30

FDA Drug

Yes

Countries

• Israel

Study Locations