NCT02304536

Brief Summary

210 women with clomiphene resistant PCOS will be randomly divided into 3 equal groups using computer generated random numbers. Group 1 will receive combined metformin and FSH, group 2 will have LOD and group 3 will act as the control group with no intervention.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

November 25, 2014

Last Update Submit

January 20, 2017

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Ovulation

    Vaginal sonography will be done regularly to check ovulation.

    6 weeks after starting the intervention

Secondary Outcomes (1)

  • Proportion of women getting pregnant

    6 months after starting the intervention

Study Arms (2)

FSH

ACTIVE COMPARATOR

will receive urinary purified FSH (Fostimon® IBSA, Switzerland) 75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9mm the dose will be increased by 37.5IU every 7 days. The cycle will be cancelled if no follicles exceed 9mm 4 weeks after starting FSH. This was combined with oral metformin (Cidophage® CID, Egypt) 500 mg three times per day.

Drug: FSH

Ovarian drilling

ACTIVE COMPARATOR

70 women will have laparoscopic ovarian drilling in which the ovaries will be stabilised by grasping the ovarian ligament and monopolar diathermy will be used to do 4-10 punctures in each ovary. The number of punctures will be individualised according to the size of the ovary. Serial vaginal ultrasound scans were done starting from the 10th day of menstruation, the frequency of monitoring will be individualized according to the women's response.

Procedure: Laparoscopic ovarian drilling

Interventions

FSHDRUG

70 women will receive urinary purified FSH (Fostimon® IBSA, Switzerland) 75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9mm the dose will be increased by 37.5IU every 7 days. The cycle will be cancelled if no follicles exceed 9mm 4 weeks after starting FSH. This was combined with oral metformin (Cidophage® CID, Egypt) 500 mg three times per day

FSH
Laparoscopic ovarian drillingPROCEDURE

70 women will have LOD in which the ovaries will be stabilised by grasping the ovarian ligament and monopolar diathermy will be used to do 4-10 punctures in each ovary. The number of punctures will be individualised according to the size of the ovary. Serial vaginal ultrasound scans were done starting from the 10th day of menstruation, the frequency of monitoring will be individualized according to the women's response.

Ovarian drilling

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clomiphene resistant PCOS

You may not qualify if:

  • Other causes of infertility
  • Hyperprolactinaemia.
  • Allergy to FSH.
  • BMI\>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BeniSuef University hospitals

BeniSuef, Egypt

RECRUITING

Cairo University Hospitals

Cairo, Egypt

RECRUITING

Related Publications (2)

  • van Wely M, Bayram N, van der Veen F, Bossuyt PM. Predictors for treatment failure after laparoscopic electrocautery of the ovaries in women with clomiphene citrate resistant polycystic ovary syndrome. Hum Reprod. 2005 Apr;20(4):900-5. doi: 10.1093/humrep/deh712. Epub 2005 Jan 7.

    PMID: 15640254BACKGROUND

  • Sam S, Dunaif A. Polycystic ovary syndrome: syndrome XX? Trends Endocrinol Metab. 2003 Oct;14(8):365-70. doi: 10.1016/j.tem.2003.08.002.

    PMID: 14516934BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

AbdelGany MA Hassan

CONTACT

+2001017801604abdelgany2@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Gynecology and Obstetrics

Study Record Dates

First Submitted

November 25, 2014

First Posted

December 2, 2014

Study Start

November 1, 2014

Primary Completion

December 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Locations

EG(2)