Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women

Infertility Clinical Trial

Official title:

Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01793038
• Other study ID #: Mific-3
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2013
• Last updated: March 5, 2013
• Start date: March 2013
• Est. completion date: September 2014

Study information

• Verified date: March 2013
• Source: Mansoura Integrated Fertility Center
• Contact: mohamad E GHanem, MD
• Phone: 00201223366955
• Email: meghanem87[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the standard first drug of treatment for ovulation induction. Ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.

Description:

To test whether CC co- treatment with chronic low dose HP uFSH versus lirizole plus chronic low dose HP uFSH in CC resistant PCOS will yield comparable results in terms of, ovulation rate, lower follicle number, lower HP uFSH dose, better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates, lower cycle cancellation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

Inclusion Criteria:

• CC resistant PCOS

• Infertile

• Females

• Age 18-38

Exclusion Criteria:

• Hyperprolactinaemia

• Cushing syndrome

• Adult onset adrenal hyperplasia

• Age > 38

• Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovary Syndrome

Intervention

Drug:
• Aromatase inhibitor (litrezole) plus uFSH arm
literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12
• clomiphene citrate-uFSH arm
clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days

Locations

Country	Name	City	State
Egypt	Mansoura Integrated fertility center	Mansoura	Dekahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura Integrated Fertility Center

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Abdellah MS. Reproductive outcome after letrozole versus laparoscopic ovarian drilling for clomiphene-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2011 Jun;113(3):218-21. doi: 10.1016/j.ijgo.2010.11.026. Epub 2011 Apr 1. — View Citation

Palomba S, Falbo A, Zullo F. Management strategies for ovulation induction in women with polycystic ovary syndrome and known clomifene citrate resistance. Curr Opin Obstet Gynecol. 2009 Dec;21(6):465-73. doi: 10.1097/GCO.0b013e328332d188. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation rate	percentage of ovulatory cycles per started and per completed cycles	30 days	No
Secondary	endometrial thickness	endmetrial thickness at time of ovulation triggering	4 weeks	No
Secondary	ongoing cycle pregnancy rate		16 weeks	No