Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/08/2011
Date assigned
26/08/2011
Last edited
17/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mostafa Abuzeid

ORCID ID

Contact details

Two Hurley Plaza
Suite 209
Flint
48503
United States of America
+ 1 810 262 9714
reprod1@hurleymc.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

195632-1

Study information

Scientific title

Controlled ovarian hyperstimulation with long versus conventional protocol of gonadotropin-releasing hormone (GnRH) antagonist in women with polycystic ovarian disease (PCOD) undergoing assisted reproduction: a randomized controlled trial

Acronym

Study hypothesis

The purpose of this study was to test the hypothesis that in women with polycystic ovarian syndrome (PCOS), early initiation of GnRH-ant. (day 1 of ovarian stimulation) is associated with higher implantation rate compared to conventional GnRH-antagonist protocol (starting on day 5 of ovarian stimulation).

Ethics approval

Institutional Review Board at Hurley Medical Center approved on October 31, 2006, Protocol number: 195632-1

Study design

Single center physician-blinded prospective randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Polycystic ovarian syndrome

Intervention

Controlled ovarian stimulation (COS) for intracytoplasmic sperm aspiration (ICSI) procedures in infertile patients with polycystic ovarian syndrome (PCOS). Two groups were studied.

The study group (group 1) received GnRH- antagonist subcutaneously (SC) starting on the same day on the beginning of COS using SC recombinant follicle stimulating hormone(r-FSH) 150-225 IU daily.

The control group (group 2) received GnRH- antagonist SC starting on treatment day 5 of SC r-FSH (150 -225 IU daily).

The implantation rate, clinical pregnancy rate, delivery rate, miscarriage rate, and the incidence of severe ovarian hyperstimulation syndrome between the two groups were compared.

Intervention type

Drug

Phase

Not Applicable

Drug names

Recombinant follicle stimulating hormone

Primary outcome measures

Implantation rates in the two groups studied evaluated at the end of the study

Secondary outcome measures

1. Clinical pregnancy, delivery, and miscarriage rates
2. The incidence of severe ovarian hyperstimulation syndrome (OHSS) in the two groups studied

Overall trial start date

01/01/2006

Overall trial end date

30/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women (age between 18-40 years) with PCOS, undergoing assisted reproductive technology (ART). PCOS was defined according to Rotterdam criteria at least 2 of the following 3 features:
1.1. Oligo and/or anovulation
1.2. Clinical and/or biochemical signs of hyperandrogenism and
1.3. Polycystic ovary on ultrasound scan (The Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group 2004)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

140

Participant exclusion criteria

Patients with:
1. Hypothyroidism
2. Hyperprolactinemia
3. Non-classical form of congenital adrenal hyperplasia
4. Cushing’s syndrome
5. Androgen-secreting tumors

Recruitment start date

01/01/2006

Recruitment end date

30/12/2009

Locations

Countries of recruitment

United States of America

Trial participating centre

Two Hurley Plaza
Flint
48503
United States of America

Sponsor information

Organisation

Hurley Medical Center (USA)

Sponsor details

Two Hurley Plaza
Suite 209
Flint
48503
United States of America
+ 1 810 262 9714
reprod1@hurleymc.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

IVF Michigan, P.C. (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes