Comparison of two oral drugs for ovulation in women with unexplained infertility: Randomised Control Trial.

Comparison of efficacy of clomiphene citrate and tamoxifen for controlled ovarian stimulation in women with unexplained infertility: Randomised Control Trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/071335

Enrollment

Registered

2024-07-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N979- Female infertility, unspecified

Interventions

Intervention1: Clomiphene citrate: Group A will receive clomiphene citrate 50mg orally from day 2 to day 6 of menstrual cycle for 3 cycles. If patient does not ovulate in the first cycle then dose wil

Eligibility

Inclusion criteria

Inclusion criteria: Women with unexplained infertility (whether primary or secondary in which couple fails to achieve pregnancy after 1 year of unprotected and regular intercourse) with following criteria: 1 Normal husband semen analysis 2 Patent fallopian tube on HSG/ chromopertubation 3 Normal uterine cavity on USG 4 Normal ovulatory function.

Exclusion criteria

Exclusion criteria: Patients with any of the following: 1 Hormonal imbalance (hypothyroidism, insulin resistance and hyperprolactinemia) 2 History of ovarian or uterine tumour 3 AFC less than 5, AMH less than 1ng/ml 4 BMI greater than 35kg/m2 or higher 5 Resistance to clomiphene citrate or tamoxifen 6 Predicted decreased endometrial receptivity ,intrauterine abnormalities, adhesions and chronic endometritis, uterine polyp or submucosal fibroid).

Design outcomes

Primary

Measure	Time frame
Comparison of mean number of dominant follicles formed during controlled ovulation stimulation among clomiphene citrate and tamoxifen over 3 cycles.Timepoint: 3 months	—

Secondary

Measure	Time frame
To compare the following parameters among the two drugs. 1.Mean Endometrial thickness 2.Mean resistivity index and pulsatility index of ovarian and uterine artery 3.Mid luteal serum progesterone. 4.Proportion of women with biochemical pregnancy by measuring beta HCG levels / urine pregnancy test 5.Proportion of women with clinical pregnancy rates ( detected by G sac visualization on transvaginal ultrasound) 6.Proportion of women with Ovarian Hyperstimulation Syndrome (OHSS) 7.Proportion of women with multiple gestation 8.Proportion of women who have miscarriages Timepoint: 3 months	—

Measure

Time frame

To compare the following parameters among the two drugs. 1.Mean Endometrial thickness 2.Mean resistivity index and pulsatility index of ovarian and uterine artery 3.Mid luteal serum progesterone. 4.Proportion of women with biochemical pregnancy by measuring beta HCG levels / urine pregnancy test 5.Proportion of women with clinical pregnancy rates ( detected by G sac visualization on transvaginal ultrasound) 6.Proportion of women with Ovarian Hyperstimulation Syndrome (OHSS) 7.Proportion of women with multiple gestation 8.Proportion of women who have miscarriages Timepoint: 3 months

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Countries

India

Contacts

Public ContactDr Pikee Saxena

Lady Hardinge medical college and associated hospitals

pikeesaxena@gmail.com9868223323

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026