Skip to content

Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist

A Prospective Randomized Study Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist Administration in Patients at Risk for Severe OHSS

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01347268
Enrollment
120
Registered
2011-05-04
Start date
2011-01-31
Completion date
2012-12-31
Last updated
2011-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In Vitro Fertilization

Keywords

coasting, withdrawing GnRH agonist, GnRH antagonist, IVF

Brief summary

Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction and is a life threatening iatrogenic complication. In patients with GnRH agonist protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated with a reduction in (E2) levels with subsequent decreasing the incidence and severity of OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS.

Detailed description

Background: Elevated estradiol (E2) levels and multiple folliculogenesis predispose to development of ovarian hyperstimulation syndrome (OHSS). In patients with GnRH agonist protocol, both withdrawing GnRH agonist and GnRH antagonist administration are associated with a reduction in (E2) levels with subsequent decreasing the incidence and severity of OHSS. This work is to compare the clinical and endocrine outcome response of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS. Purpose: To compare the decreased levels of estradiol (E2), coasting days, severity of OHSS and pregnancy outcomes of cycles in which GnRH agonist withdrawing with cycles in which the GnRH antagonist administration in patients at risk of severe OHSS. Methods: a prospective randomized study was designed to evaluate clinical and endocrine outcome in two different coasting protocols. Women (n=120) under controlled ovarian hyperstimulation with GnRH agonist protocol at the risk of OHSS (≧20 follicles \>12 mm development with E2\> 4000 pg/ml) randomized into two groups. Group I (n=60), withdrawing GnRH agonists and continued low dose r-FSH 75 IU. Group II (n=60), GnRH antagonist administration and continued low dose r-FSH 75 IU. When E2\< 3000 pg/ml, hCG was given. Oocyte retrieval was performed 36 h after hCG administration. The primary outcome measures were the decreased levels of estradiol (E2) and the days of coasting. The secondary outcome measures were number of oocytes retrieved, pregnancy rate and the incidence of OHSS. anticipated results: No significant differences were seen in the levels of estradiol (E2) decreased, the days of coasting, number of oocytes, pregnancy rate and the incidence of OHSS. GnRH antagonist is not necessary in coasting treatment while stop GnRH agonist.

Interventions

PROCEDUREGnRH antagonist

GnRH antagonist administration and continued low dose r-FSH 75 IU

PROCEDUREwithdrawing GnRH agonists

withdrawing GnRH agonists and continued low dose r-FSH 75 IU

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
Yes

Inclusion criteria

* the risk of ovarian hyperstimulation syndrome

Exclusion criteria

* allergic to GnRH antagonist

Design outcomes

Primary

MeasureTime frameDescription
decreased levels of estradiol (E2)one year
The days of coastingone yearThe interval between the day of starting intervention and the day of hCG administration

Secondary

MeasureTime frame
number of oocytes retrievedone year
pregnancy rateone year
the incidencess of OHSSone year

Countries

Taiwan

Contacts

Primary ContactJiann-Loung Hwang, MD
m001015@ms.skh.org.tw886-2-28332211
Backup ContactHeng-Ju Chen, MD
m004983@ms.skh.org.tw886-2-28332211

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026