Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01347268
Study type Interventional
Source Shin Kong Wu Ho-Su Memorial Hospital
Contact Jiann-Loung Hwang, MD
Phone 886-2-28332211
Email m001015@ms.skh.org.tw
Status Recruiting
Phase Phase 4
Start date January 2011
Completion date December 2012

See also
  Status Clinical Trial Phase
Completed NCT00696878 - Corifollitropin Alfa in Participants Undergoing Repeated Controlled Ovarian Stimulation (COS) Cycles Using a Multiple Dose Gonadatropin Releasing Hormone (GnRH) Antagonist Protocol (Study 38825)(P05714) Phase 3
Recruiting NCT04122729 - N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
Not yet recruiting NCT02534857 - A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment N/A
Recruiting NCT01406600 - Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles N/A
Completed NCT01406028 - Does Emotional Support Decrease In Vitro Fertilization Stress? N/A
Withdrawn NCT00541892 - Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine Phase 2
Completed NCT00708383 - in Vitro Fertilization (IVF) Media Protein and Live Birth Rates N/A
Completed NCT03627533 - The Differences of Oocyte Maturation, Granulosa Cell Apoptosis Index Between Electroacupuncture And Sham Groups IVF N/A
Recruiting NCT04160611 - What Amount of Stress is Enough for a Successful Conception? Phase 3
Suspended NCT01600794 - To Evaluate The Anrogens and Ovary Function in In Vitro Fertilization N/A
Completed NCT01507376 - Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity Phase 3
Terminated NCT00866008 - A Study of the Effects of a Novel Ovarian Stimulation Regimen on Embryo Aneuploidy Rates in In Vitro Fertilization (IVF) Phase 4
Recruiting NCT04082650 - Vitamin D and Pregnancy Outcome in PCOS Patients N/A
Recruiting NCT03758833 - eSET or eDET Associated to PGT in IVF N/A
Not yet recruiting NCT04407871 - Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct) N/A
Recruiting NCT03345030 - The Role of DNA Damage of Granulosa Cell on Oocyte Quality and in Vitro Fertilization Outcome N/A
Not yet recruiting NCT06367985 - CAPA-IVM Culture With Low Oxygen Tension N/A
Not yet recruiting NCT03090438 - IVF Outcomes After Varicocele Repair N/A
Terminated NCT01614067 - Delayed Start to Ovarian Stimulation Phase 4
Completed NCT01343992 - Bed Rest or no Bed Rest? N/A