Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility (NCT00610077) | Clinical Trial Compass
CompletedPhase 3
Letrozole vs. Clomiphene Citrate in Patients With Anovulatory Infertility
India55 participantsStarted 2004-12
Plain-language summary
OBJECTIVE: To compare the effectiveness of letrozole and clomiphene citrate (CC) in patients with anovulatory infertility. DESIGN: Open, prospective, randomized, parallel group, multicentric, comparative trial. SETTING: Out patient clinics of infertility centers in India. PATIENT(S): Fifty-five patients with anovulatory infertility were recruited. Twenty-seven patients (59 cycles) were given letrozole and twenty-eight patients (68 cycles) were given CC. Both drugs were given orally on days 3-7 of menstrual cycle. INTERVENTION(S): Letrozole, CC, ovulation induction, vaginal micronized progesterone, IUI.
Who can participate
Age range
20 Years – 38 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Females with anovulatory infertility 20-38 years of age.
* Diagnosis of anovulatory infertility as established by standard criteria.
* Normal Pelvic USG and bilateral tubal patency
* Willingness and giving written Informed Consent.
Exclusion Criteria:
* Uterine and adnexal pathology e.g. leiomyomata
* Ovarian cyst
* Hyperprolactinaemia
* Hyperthyroidism or Hypothyroidism\*
* FSH \>9mIU/ml (during early follicular phase).\* (As per Chemoluminescence method)
* Previous surgery related to genital tract as per history
* Appendicitis, peritonitis, genital tuberculosis as per history and/or having an abnormal pelvic anatomy
* Impaired hepatic /renal function
* Diabetes mellitus/Random blood sugar- \> 140mg/dl
* Drugs likely to interfere with ovulation
* Alcohol intake as per history
* History of hypersensitivity to the study drug or to its excipients
* Planned travel outside the study area for a substantial portion (\>5 days) of the study period by potential participants
* Lack of willingness to give informed written consent
* Participation in any clinical study within the preceding 1 month
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ovulation rate (ovulatory cycles/ all treatment cycles) by Ultrasonography (USG).