Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corifollitropin Alfa Application in PCOS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

Brief Summary:
Corifollitropin alfa, single dose administered sustains multiple follicular development for 7 days. However, It may induce ovarian hyperstimulation syndrome (OHSS), especially in high responder women such as patients of polycystic ovary syndrome (PCOS). In GnRH antagonist protocol with agonist triggering of final oocyte maturation, following embryo cryopreservation can almost eliminate the risk of OHSS. To decrease the injection burden and prevent OHSS in PCOS patients undergoing IVF treatment, ovarian hyperstimulation with Corifollitropin alfa in GnRH antagonist protocol and GnRH agonist triggering of final oocyte maturation, following elective embryo cryopreservation was designed in this study. The purpose of this trial was conducted to confirmed whether this novel protocol could prevent OHSS, decreased the injection burden of PCOS patients and single dose corifollitropin alfa could support multiple follicular growth for 7 days.

Condition or disease Intervention/treatment Phase
In Vitro Fertilization Drug: Corifollitropin alfa Phase 4

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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].


Secondary Outcome Measures :
  1. numbers of oocytes retrieved [ Time Frame: one month ]
  2. 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.


  3. No. of embryo frozen [ Time Frame: one month ]

Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The diagnosis of PCOS was according Rotterdam criteria ( twoi of three) included:

  • chronic anovulation manifested by the symptoms of oligomenorrhoea
  • ultrasonographic evidence of polycystic enlarged ovary with over 10 peripherally located follicles of 3-8mm diameter around a dense central stroma
  • hyperandrogenaemia (serum testosterone concentrations over 0.8 ng/ml) or clinical hyperandrogenism.

Exclusion Criteria:

  • A diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen-producing tumours, hyperprolactinaemia and thyroid dysfunction were all excluded.
  • patients older than 38 years or with serum FSH level over 12 mIU/ml.
  • patients wiht previous ovarian surgery
  • husband with non-obstructive azoospermia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215135


Contacts
Layout table for location contacts
Contact: Jiann-Loung Hwang, MD 886-2-28332211 ext 3879 m001015@ms.skh.org.tw

Locations
Layout table for location information
Taiwan
Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Jiann-Loung Hwang, MD    886-2-28332211 ext 3879    m001015@ms.skh.org.tw   
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
Layout table for investigator information
Study Chair: Jiann-Loung Hwang, MD Department of Obstetrics and Gynecology, Shin Kong Wu Ho-Su Memorial Hospital

Layout table for additonal information
Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT02215135    
Other Study ID Numbers: SKH-8302-101-DR-15
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Corifollitropin alfa
polycystic ovarian syndrome (PCOS)
controlled ovarian hyperstimulation (COS)
GnRH antagonist protocol
Ovarian hyperstimulation syndrome (OHSS)