Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT04797338Other id0245-17-ASF

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 100 participants (estimated)
Sponsor: Assaf-Harofeh Medical Center · Other gov
Design: Randomized · Open label (no masking)
Countries: 1 country
Israel
Start: 29 Dec 2017
Primary completion: 30 Sept 2021 (estimated)
Completion: 30 Sept 2021 (estimated)
First posted: 15 Mar 2021
Last update posted: 1 Apr 2021
Conditions: Pregnancy Early · Miscarriage · Ovarian Hyperstimulation Syndrome

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019202020212022

Ph 4
Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders
NCT04797338
29 Dec 2017 to est. 30 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Synarel, 0.2 Mg/Inh Nasal SprayDrug
EstrofemDrug
UtrogestanDrug
Hydroxyprogesterone CaproateDrug

Arms2

Active comparator
GnRHa treatment based luteal support
Patients will initiate 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 hCG results, the treatment will be stopped.
Active comparator
Estrogen and progesterone supplementation
Patients will start treatment with 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 progesterone retard 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 hCG results, the treatment will be continued up to 9+0 weeks of pregnancy.

Primary outcomes2

Outcomes the sponsor listed as primary.

clinical pregnancy rate
Time frame · 3 weeks after positive serum bHCG results
Registry description
an ultrasound visualization of one or more gestational sacs
Clinical pregnancy rate with fetal heart beat
Time frame · 3 weeks after positive serum bHCG results
Registry description
clinical pregnancy with a demonstration of fetal heart by ultrasound visualization

Secondary outcomes(2)

Miscarriage rate
Time frame · from the demonstration of a clinical pregnancy (3 weeks after positive serum bHCG results) up to 22 weeks
Registry description
spontaneous loss of a clinical pregnancy before 22 completed weeks of gestational age
Ovarian hyperstimulation syndrome (OHSS) rate
Time frame · up to 12 days post embryo transfer
Registry description
An exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It may be classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2006

6 results

Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles.

Tesarik et al. 2006Human reproduction (Oxford, England)cited by 89

PMID 16926261DOI 10.1093/humrep/del173PUB-16926261

Full text at the publisher6 results

Publisher page See results (6)

Indexing hint: Clinical trial · 2004

6 results

Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation.

Tesarik et al. 2004Human reproduction (Oxford, England)cited by 84

PMID 15070873DOI 10.1093/humrep/deh235PUB-15070873

Full text at the publisher6 results

Publisher page See results (6)

PubMed tag: none · 1995

1 result

Administration of a gonadotropin-releasing hormone agonist during pregnancy: follow-up of 28 pregnancies exposed to triptoreline.

Elefant et al. 1995Fertility and sterilitycited by 20

PMID 7720926DOI 10.1016/s0015-0282(16)57557-8PUB-07720926

Full text at the publisher1 result

Publisher page See results (1)

More studies

1 study on this page

PubMed tag: none · 2016

Intranasal gonadotropin-releasing hormone agonist (GnRHa) for luteal-phase support following GnRHa triggering, a novel approach to avoid ovarian hyperstimulation syndrome in high responders.

Bar-Hava et al. 2016Fertility and sterilitycited by 29

PMID 27114332DOI 10.1016/j.fertnstert.2016.04.004PUB-27114332

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * High responder patients, defined as either reaching a serum estradiol levels of ≥ 3500 pg/ml on the day of trigger or having ≥ 15 oocytes retrieved. * Increased risk for OHSS (PCOS, previous history of OHSS, high antral follicle count (AFC) etc.). Exclusion Criteria: * Repeated implantation failure (3 or more previous failed embryo transfer cycles while transferring good quality embryos). * Oocyte donation, fertility preservation or Freeze all (freezing all the embryos) cycles. * Moderate to severe endometriosis * An evidence of hydrosalpinx

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