Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
In Vitro Fertilization |
Procedure: GnRH antagonist Procedure: withdrawing GnRH agonists |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Study Comparing Coasting by Withholding GnRH Agonist With GnRH Antagonist Administration in Patients at Risk for Severe OHSS |
- decreased levels of estradiol (E2) [ Time Frame: one year ] [ Designated as safety issue: No ]
- The days of coasting [ Time Frame: one year ] [ Designated as safety issue: No ]The interval between the day of starting intervention and the day of hCG administration
- number of oocytes retrieved [ Time Frame: one year ] [ Designated as safety issue: No ]
- pregnancy rate [ Time Frame: one year ] [ Designated as safety issue: No ]
- the incidencess of OHSS [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: withdrawing GnRH agonists |
Procedure: withdrawing GnRH agonists
withdrawing GnRH agonists and continued low dose r-FSH 75 IU
|
| Experimental: GnRH antagonist administration |
Procedure: GnRH antagonist
GnRH antagonist administration and continued low dose r-FSH 75 IU
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 38 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- the risk of ovarian hyperstimulation syndrome
Exclusion Criteria:
- allergic to GnRH antagonist
Contacts and Locations| Contact: Jiann-Loung Hwang, MD | 886-2-28332211 ext 3879 | m001015@ms.skh.org.tw |
| Contact: Heng-Ju Chen, MD | 886-2-28332211 ext 3870 | m004983@ms.skh.org.tw |
| Taiwan | |
| Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memerial Hospital | Recruiting |
| Taipei, Taiwan | |
| Contact: Jiann-Loung Hwang, MD 886-2-28332211 ext 3879 m001015@ms.skh.org.tw | |
| Contact: Heng-Ju Chen, MD 886-2-28332211 ext 3870 m004983@ms.skh.orh.tw | |
| Study Chair: | Jiann-Loung Hwang, MD | Shin-Kong Wu Ho-Su Memerial Hospital |
More Information
No publications provided
| Responsible Party: | Jiann-Loung Hwang, Shin-Kong Wu Ho-Su Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT01347268 History of Changes |
| Other Study ID Numbers: | SKH-8302-100-DR-08 |
| Study First Received: | April 26, 2011 |
| Last Updated: | May 2, 2011 |
| Health Authority: | Taiwan: Institutional Review Board |
Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
|
coasting withdrawing GnRH agonist GnRH antagonist IVF |
Additional relevant MeSH terms:
|
Deslorelin Triptorelin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Luteolytic Agents Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Therapeutic Uses Antineoplastic Agents, Hormonal Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013