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hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
HMG
rFSH
Sponsored by
Zekai Tahir Burak Women's Health Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring IVF, ICSI, OHSS, PCOS, recFSH, HMG

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with PCOS

Exclusion Criteria:

  • Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study

Sites / Locations

  • Zekai Tahir Burak women's research and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

menotrophin

recombinant FSH

Arm Description

In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.

Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.

Outcomes

Primary Outcome Measures

the incidence of OHSS
peak serum E2 levels

Secondary Outcome Measures

the need of coasting,
number of intermediate follicles
fertilization rate

Full Information

First Posted
May 31, 2011
Last Updated
March 28, 2012
Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01365936
Brief Title
hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF
Official Title
Influence of Ovarian Stimulation With hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There have been some controversies regarding the use of preparations with LH activity in patients with polycystic ovary syndrome (PCOS) who have high endogenous LH activity. In this research we aimed to compare urinary menotrophin versus recombinant FSH (rFSH) with respect to the prevention of OHSS
Detailed Description
Polycystic ovary syndrome was diagnosed according to the Rotterdam criteria. Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study. All of our patients were given combined oral contraceptive (Yasmin) prior to ovulation induction cycles. Leuprolide Acetate (Lucrin daily; Abbott, Istanbul) therapy was started in mid-luteal phase to induce pituitary down regulation, and was initiated at a dose of 1.0 mg SC daily until pituitary down-regulation was established. The leuprolide acetate dose was then reduced to 0.5 mg daily until the day of human chorionic gonadotropin (hCG) administration. After GnRH analogue suppression was achieved, the patients were randomized using block randomization (block of two) to stimulation with hMG (Menogon; Ferring Pharmaceuticals. Istanbul) or rFSH (Gonal-F; Serono Istanbul). Starting dose was 150IU for the first 3 days of stimulation, after which daily dosing was determined individually. Serial Estrodiol (E2) levels and two-dimensional follicle measurements by transvaginal ultrasonography (LOGIC 200 PRO, General Electric, Korea) were performed until at least two dominant follicles reached dimensions of 18 mm or greater in diameter. Human chorionic gonadotropin (Pregnyl, Organon, 10,000 IU- IM) was then administered, followed by transvaginal oocyte retrieval 36 hours later. The criteria of coasting in our institute were serum E2 >3600 pg/ml and multiple intermediate follicle. During coasting period, gonadotropin was withheld, but leuprolide acetate was continued at 0.5mg/d. ICSI was performed for all the patients. Fertilization was assessed at 20h (±1h), and embryo quality was assessed at 28, 44, and 68h (±1h) after oocyte retrieval. A top- quality embryo was defined as four to five cells on day 2, seven or more cells on day 3, and no multinucleation. Vaginal progesterone gel 90 mg/day 8% (Crinone;Serono) for luteal support was given from the oocyte retrieval until the clinical pregnancy (9-10 weeks of gestation) or negative serum βhCG test (13-15 days after embryo transfer).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
IVF, ICSI, OHSS, PCOS, recFSH, HMG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
menotrophin
Arm Type
Active Comparator
Arm Description
In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Arm Title
recombinant FSH
Arm Type
Active Comparator
Arm Description
Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Intervention Type
Drug
Intervention Name(s)
HMG
Other Intervention Name(s)
Menotrophin
Intervention Description
In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Intervention Type
Drug
Intervention Name(s)
rFSH
Intervention Description
Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
Primary Outcome Measure Information:
Title
the incidence of OHSS
Time Frame
6 Months
Title
peak serum E2 levels
Time Frame
6 months
Secondary Outcome Measure Information:
Title
the need of coasting,
Time Frame
6 months
Title
number of intermediate follicles
Time Frame
6 months
Title
fertilization rate
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with PCOS Exclusion Criteria: Patients older than 38 years or with serum FSH level ≥12mIU/ml and a history of ovarian surgery were excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Figen A Turkcapar, MD
Organizational Affiliation
Zekai Tahir Burak Women's Health Research and Training Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zekai Tahir Burak women's research and Training Hospital
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24520446
Citation
Figen Turkcapar A, Seckin B, Onalan G, Ozdener T, Batioglu S. Human Menopausal Gonadotropin versus Recombinant FSH in Polycystic Ovary Syndrome Patients Undergoing In Vitro Fertilization. Int J Fertil Steril. 2013 Jan;6(4):238-43. Epub 2013 Mar 3.
Results Reference
derived

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hMG or Recombinant FSH on OHSS Prevention in PCOS Patients Undergoing IVF

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