NCT02215135

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

June 4, 2014

Last Update Submit

August 11, 2014

Conditions

In Vitro Fertilization

Keywords

Corifollitropin alfapolycystic ovarian syndrome (PCOS)controlled ovarian hyperstimulation (COS)GnRH antagonist protocolOvarian hyperstimulation syndrome (OHSS)

Outcome Measures

Primary Outcomes (1)

  • Number of participants with severe OHSS

    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. \[Golan A, Ron-el R, Herman A, Soffer Y, Weinraub Z, Caspi E.Ovarian hyperstimulation syndrome: an update review. ObstetGynecol Surv. 1989;44:430-40\].

    one month

Secondary Outcomes (3)

  • numbers of oocytes retrieved

    one month

  • embryo quality

    one month

  • No. of embryo frozen

    one month

Other Outcomes (1)

  • Clinical pregnancy rate in the frozen-thawed embryo transfer cycle

    6 months

Study Arms (1)

Corifollitropin in PCOS

EXPERIMENTAL

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

Interventions

Corifollitropin alfaDRUG

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.

Also known as: elonva
Corifollitropin in PCOS

Eligibility Criteria

Age20 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian Hyperstimulation Syndrome

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Jiann-Loung Hwang, MD

    Department of Obstetrics and Gynecology, Shin Kong Wu Ho-Su Memorial Hospital

    STUDY CHAIR

Central Study Contacts

Jiann-Loung Hwang, MD

CONTACT

886-2-28332211m001015@ms.skh.org.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

August 13, 2014

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations

TW(1)