Corifollitropin Alfa Application in PCOS Patients
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|ClinicalTrials.gov Identifier: NCT02215135|
Recruitment Status : Unknown
Verified August 2014 by Shin Kong Wu Ho-Su Memorial Hospital.
Recruitment status was: Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
|Condition or disease||Intervention/treatment||Phase|
|In Vitro Fertilization||Drug: Corifollitropin alfa||Phase 4|
BACKGROUNG: Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of ovulation induction. Therefore, Corifollitropin alfa, long acting recombinant follicular stimulation hormone (rFSH) application in PCOS women is warning. However, corifollitropin alfa could decrease the injection burden of patients undergoing IVF/ICSI treatment. In previous studies, embryo cryopreservation following GnRH agonist triggering final oocyte maturation in GnRH antagonist protocol can almost eliminate the risk of OHSS. This study was designed to analyze whether ovarian hyperstimulation in PCOS women with Corifollitropin alfa in GnRH antagonist protocol and GnRH agonist triggering, following freezing all embryos can decrease the injection burden without OHSS complication.
PURPOSE: To assess whether single dose Corifollitropin alfa sustains multiple follicular growth for seven days in GnRH antagonist protocol application in PCOS women, following embryo cryopreservation after GnRH agonist triggering can decrease injection benefit without OHSS complication.
METHODS: This prospective ,single center, observational study, thirty to fifty PCOS women aged 20-38 years old, In GnRH antagonist protocol, a single dose corifollitropin alfa was administered for ovarian stimulation (S1, stimulation D1). Seven days later, rFSH was daily injected to stimulate follicle development according to the ovarian response. GnRH antagonist was administered daily from S5 until the day of final oocyte maturation. GnRH agonist was given to replace hCG to trigger final oocyte maturation when three follicles reached 17 mm in size. The IVF or ICSI was planned then all embryos were elective cryopreservation. Transfer of embryos was performed in a subsequent frozen-thawed ET cycles. Primary outcome measure was the incidence of OHSS. The secondary outcome measures were numbers of oocytes retrieval, numbers of embryos frozen and pregnancy rate of subsequent FET cycles.
ANTICIPATED RESULTS: Decreasing the injection burden and maximal oocytes were retrieved without severe OHSS complication.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Corifollitropin Alfa in Combination With Elective Cryopreservation of All Embryos After GnRH Agonist Triggering of Final Oocyte Maturation in PCOS Patients- a Prospective, Observational Proof-of -Concept Study|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||June 2015|
Experimental: Corifollitropin in PCOS
In GnRH antagonist protocol, a single dose corifollitropin alfa was administered for ovarian stimulation following rFSH daily injection to stimulate follicle development. GnRH agonist was given to trigger final oocyte maturation when three follicles reached 17 mm in size. The IVF or ICSI was planned then all embryos were elective cryopreserved.
Drug: Corifollitropin alfa
In GnRH antagonist protocol, ovarian stimulation with single dose of 100μg (BW≦60 kg) or 150μg (BW> 60 kg) corifollitropin alfa (Elonva, SC), followed 1 week later (stimulation day 8) by a daily dose of rFSH to the day of GnRH agonist triggering final oocyte maturation.
Other Name: elonva
- Number of participants with severe OHSS [ Time Frame: one month ]The patients were assessed for signs and symptoms of OHSS on 3, 6, and 9 days after oocyte retrieval including history taking, physical examination, ultrasound scan, and blood tests for hematocrit, complete blood counts.The severity of OHSS was according to the classification of Golan et al. [Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E.Ovarian hyperstimulation syndrome: an update review. ObstetGynecol Surv. 1989;44:430-40].
- numbers of oocytes retrieved [ Time Frame: one month ]
- embryo quality [ Time Frame: one month ]
Grade 1 embryos consisted of symmetrical blastomeres of approximately equal size and without anucleate fragments.
Grade 2 embryos had blastomeres of even or uneven size and had 10% of the volume of embryos filled with anucleate fragments.
Grade 3 embryos had anucleate fragments occupying between 10 and 50% of the volume of the embryos.
Grade 4 embryos had anucleate fragments .50% of the volume of the embryos.
- No. of embryo frozen [ Time Frame: one month ]
- Clinical pregnancy rate in the frozen-thawed embryo transfer cycle [ Time Frame: 6 months ]Serum β-HCG level was measured 14 days after embryo transfer. Clinical pregnancy was defined as the presence of fetal cardiac activity on transvaginal ultrasonography at 7 weeks of gestation.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215135
|Contact: Jiann-Loung Hwang, MD||886-2-28332211 ext email@example.com|
|Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital||Recruiting|
|Contact: Jiann-Loung Hwang, MD 886-2-28332211 ext 3879 firstname.lastname@example.org|
|Study Chair:||Jiann-Loung Hwang, MD||Department of Obstetrics and Gynecology, Shin Kong Wu Ho-Su Memorial Hospital|