A Comparison of Letrozole and Clomifene Citrate

NCT02647424 | Unknown

• 1 other identifier: HKU-VL-LCC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome; Subfertility

Outcome Measures

Primary Outcomes (1)

• FSH concentrations

  Alternative day during ovulation induction cycle (for about 3 month)

Secondary Outcomes (5)

• LHconcentration

  Alternative day during ovulation induction cycles (for about 3 month)

• Endometrial Thickness

  Monitoring during ovulation induction cycle (for about 3 month)

• Oestradiol concentration

  Alternative day during ovulation induction cycles (for about 3 month)

• Progesterone concentration

  Alternative day during ovulation induction cycles (for about 3 month)

• Number of growing follicles

  Monitoring during OI cycles (for about 3 month)

Study Arms (2)

PCOS group

OTHER

PCOS women with anovulation

Drug: Letrozole; Drug: Clomiphene

Ovulatory group

OTHER

Ovulatory group planned for intra-uterine insemination

Drug: Letrozole; Drug: Clomiphene

Interventions

Letrozole DRUG

Letrozole 2.5 mg daily from Day 2 to 6

Also known as: Letrozole group

Ovulatory group; PCOS group

Clomiphene DRUG

After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given

Also known as: Clomiphene group

Ovulatory group; PCOS group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong, 852, Hong Kong

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Letrozole; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Vivian Lee, MBBS, MRCOG

  Queen Mary Hospital / University of Hong Kong.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivian Lee, MBBS, MRCOG

CONTACT

22553400; v200lee@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 6, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

HK (1)