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A Comparison of Letrozole and Clomifene Citrate

Primary Purpose

Polycystic Ovarian Syndrome, Subfertility

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Letrozole
Clomiphene
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

  • Age of women 18-39 years
  • Irregular menstrual cycles with anovulation (cycle >35 days) together with polycystic ovaries on pelvic scanning or laboratory/clinical hyperandrogenism (in PCOS group)
  • Regular cycle of 25-35 days cycle for the ovulatory women group
  • Body mass index </= 30 kg/m2

Exclusion criteria:

  • Couples undergoing ART treatment cycles
  • History of ovarian surgery
  • Drug allergy to CC or LTZ
  • History of diabetes mellitus or other severe medical diseases
  • Refusal to join the study

Sites / Locations

  • Queen Mary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

PCOS group

Ovulatory group

Arm Description

PCOS women with anovulation

Ovulatory group planned for intra-uterine insemination

Outcomes

Primary Outcome Measures

FSH concentrations

Secondary Outcome Measures

LHconcentration
Endometrial Thickness
Oestradiol concentration
Progesterone concentration
Number of growing follicles

Full Information

First Posted
December 29, 2015
Last Updated
October 26, 2016
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02647424
Brief Title
A Comparison of Letrozole and Clomifene Citrate
Official Title
A Comparison of Hormonal Profile and the Follicular Development Between Letrozole and Clomifene Citrate in Anovulatory Women With Polycystic Ovary Syndrome and Ovulatory Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies, affecting 5% to 10% of women of reproductive age. Women with PCOS suffer from anovulatory infertility. Following lifestyle modification with weight reduction in obese PCOS women, clomifene citrate (CC) is considered the first line treatment for ovulation induction (OI) in these women. 75-80% of women will ovulate after CC administration. However, there is a discrepancy between the ovulation rate and pregnancy rate, which was reported to be 22% per each ovulating cycles after CC. Other alternatives, including gonadotropin injections and laparoscopic ovarian drilling, carried different disadvantages, such as costly treatment and risks of ovarian hyperstimulation syndrome and multiple pregnancy rate in gonadotrophin therapy and surgical risks and risk of ovarian failure in surgical treatment. The use of aromatase inhibitor, letrozole (LTZ), in reproductive medicine started in 2001. After this publication, there have been many groups of investigators studying the use of LTZ either in OI or ovarian stimulation in IVF cycles. A large multicentre randomized trial reported a significantly higher ovulation rate and live-birth rate comparing LTZ with CC. In majority of the publications, the multiple pregnancy rate was lower in LTZ group than in CC group. This can be attributed to the higher chance of monofollicular development after LTZ compared with CC. However, there is no information comparing the hormonal profile and follicular development after letrozole and CC. Mild ovarian stimulation using LTZ or CC in conjunction with intrauterine insemination is commonly offered to ovulatory women with unexplained infertility, minimal endometriosis or mild factor to improve the pregnancy rate. There is again no information comparing the hormonal profile and follicular development after letrozole and CC in ovulatory women. The aim of this study is to compare the hormonal profile after the use of LTZ and CC in anovulatory PCOS women and ovulatory women with unexplained subfertility. The hypothesis is that the FSH risk after LTZ is shorter than that of CC.
Detailed Description
Polycystic ovary syndrome (PCOS) is one of the most common endocrinopathies, affecting 5% to 10% of women of reproductive age. Women with PCOS suffer from anovulatory infertility. Following lifestyle modification with weight reduction in obese PCOS women, clomifene citrate (CC) is considered the first line treatment for ovulation induction (OI) in these women. 75-80% of women will ovulate after CC administration. However, there is a discrepancy between the ovulation rate and pregnancy rate, which was reported to be 22% per each ovulating cycles after CC. Other alternatives, including gonadotropin injections and laparoscopic ovarian drilling, carried different disadvantages, such as costly treatment and risks of ovarian hyperstimulation syndrome and multiple pregnancy rate in gonadotrophin therapy and surgical risks and risk of ovarian failure in surgical treatment. The use of aromatase inhibitor, letrozole (LTZ), in reproductive medicine started in 2001. After this publication, there have been many groups of investigators studying the use of LTZ either in OI or ovarian stimulation in IVF cycles. A large multicentre randomized trial reported a significantly higher ovulation rate and live-birth rate comparing LTZ with CC. In majority of the publications, the multiple pregnancy rate was lower in LTZ group than in CC group. This can be attributed to the higher chance of monofollicular development after LTZ compared with CC. However, there is no information comparing the hormonal profile and follicular development after letrozole and CC. Mild ovarian stimulation using LTZ or CC in conjunction with intrauterine insemination is commonly offered to ovulatory women with unexplained infertility, minimal endometriosis or mild factor to improve the pregnancy rate. There is again no information comparing the hormonal profile and follicular development after letrozole and CC in ovulatory women. The aim of this study is to compare the hormonal profile after the use of LTZ and CC in anovulatory PCOS women and ovulatory women with unexplained subfertility. The hypothesis is that the FSH risk after LTZ is shorter than that of CC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Subfertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PCOS group
Arm Type
Other
Arm Description
PCOS women with anovulation
Arm Title
Ovulatory group
Arm Type
Other
Arm Description
Ovulatory group planned for intra-uterine insemination
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Letrozole group
Intervention Description
Letrozole 2.5 mg daily from Day 2 to 6
Intervention Type
Drug
Intervention Name(s)
Clomiphene
Other Intervention Name(s)
Clomiphene group
Intervention Description
After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given
Primary Outcome Measure Information:
Title
FSH concentrations
Time Frame
Alternative day during ovulation induction cycle (for about 3 month)
Secondary Outcome Measure Information:
Title
LHconcentration
Time Frame
Alternative day during ovulation induction cycles (for about 3 month)
Title
Endometrial Thickness
Time Frame
Monitoring during ovulation induction cycle (for about 3 month)
Title
Oestradiol concentration
Time Frame
Alternative day during ovulation induction cycles (for about 3 month)
Title
Progesterone concentration
Time Frame
Alternative day during ovulation induction cycles (for about 3 month)
Title
Number of growing follicles
Time Frame
Monitoring during OI cycles (for about 3 month)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age of women 18-39 years Irregular menstrual cycles with anovulation (cycle >35 days) together with polycystic ovaries on pelvic scanning or laboratory/clinical hyperandrogenism (in PCOS group) Regular cycle of 25-35 days cycle for the ovulatory women group Body mass index </= 30 kg/m2 Exclusion criteria: Couples undergoing ART treatment cycles History of ovarian surgery Drug allergy to CC or LTZ History of diabetes mellitus or other severe medical diseases Refusal to join the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Lee, MBBS, MRCOG
Phone
22553400
Email
v200lee@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Lee, MBBS, MRCOG
Organizational Affiliation
Queen Mary Hospital / University of Hong Kong.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vivian CY Lee, MBBS
Phone
852-22553400
Email
v200lee@hku.hk
First Name & Middle Initial & Last Name & Degree
Vivian Lee
First Name & Middle Initial & Last Name & Degree
Ernest HY Ng, MD

12. IPD Sharing Statement

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A Comparison of Letrozole and Clomifene Citrate

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