Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: ovulation induction with combined letrozole and clomiphene.
: Women will be randomly assigned to receive a combination of 2.5 mg letrozole and 50 mg CC daily for 5 days starting from da
Sponsors
Dr Soumya Ranjan Panda
Eligibility
Inclusion criteria
Inclusion criteria: Patients attending the infertility clinic in the Department of Obstetrics and Gynecology at AIIMS, Mangalagiri will be included in our study if the following inclusion criterias are fulfilled. 1) The age of the patient is between 20 yrs to 40 yrs 2) Diagnosed as PCOS according to Rotterdam critetria. 3) a normal hysterosalpingogram or laparoscopy has been documented; 4) no recorded history of pelvic surgery and/or pelvic inflammatory disease; 5) Male partners having a normal semen analysis, according to the 2010 World Health Organization criteria, within the preceding 6 months and 6) no history of treatment with exogenous gonadotropin.
Exclusion criteria
Exclusion criteria: 1) Endocrine factors other than anovulatory PCOS like hyperprolactinemia, hypothalamic amenorrhea, premature ovarian failure and ovarian tumor or clinical suspicion of other etiologies that mimic PCOS warranting additional evaluation. 2) uncorrected thyroid disease; uncontrolled type 1 or 2 diabetes mellitus or hypertension. 3) allergy or contraindications to letrozole or CC. 4) Other associated factors of infertility like male factor, uterine factor and endometriosis.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| pregnancy loss, including biochemical miscarriage or ectopic pregnancyTimepoint: upto 20 weeks of pregnancy;size and number of developing follicles and endometrial thickness noted in TVS on cycle day 12â??14;Timepoint: 10-12 days after randomisation;adverse events related to the medicationsTimepoint: throughout the study duration;clinical pregnancyTimepoint: 6-8 weeks after randomisation;conceptionTimepoint: 4-6 weeks after randomisation;live birthTimepoint: at the time of delivery of the patient;multiple pregnancyTimepoint: 14-16 weeks after randomisation | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be ovulation, defined as a rupture of dominant follicle as on TVS or mid-luteal progesterone level more than 3 ng/mL. This was tested on cycle day 21 Timepoint: 2 to 3 weeks after randomisation | — |
Countries
India
Contacts
Public ContactSharmila
AIIMS, Mangalagiri
Outcome results
None listed