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Comparison of Clomid and Lezra with Lezra for Ovulation Induction in Clomid Resistant PCOS Case

H

HITEC-Institute of Medical Sciences

Status and phase

Enrolling
Phase 1

Conditions

Polycystic Ovarian Syndrome

Treatments

Drug: Clomiphene Citrate and letrozole

Study type

Interventional

Funder types

Other

Identifiers

NCT06813118
HITECIMSTAXILLA

Details and patient eligibility

About

Clomiphene citrate resistant i.e failure to ovulate after 6 cycles of ovulation induction effects 15-40% of patients with PCOS.Two treatment groups will be formed one recieving letrozole alone and another recieving CC and letrozole combined.Mature follicles and endometrial thickness will be checked by transvaginal ultrasound and results will be recorded.

Full description

Subfertility is characterized by the inability to achieve conception despite engaging in regular unprotected sexual intercourse for 1-2 years.PCOS exhibits chacteristic traits such as obesity,heightened insulin resistance accompanied by compensatory hyperinsulinemia,oligo/anovulation and subfertility.Clompiphene citrate induces ovarian stimulation.Letrozole ,an aromatase inhibitor emerges as a novel medication with comparable efficacy to CC as a first line treatment for inducing ovulation in cases of anovulation.

Enrollment

42 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • women of 20-40 years with a history of PCOS and resistant to CC

Exclusion criteria

  • Premature ovarian insufficiency
  • Husband has oligo azoospermia
  • Hypothyroidism
  • Hyperprolactinemia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 2 patient groups

group 1
Experimental group
Description:
clomiphene citrate and letrozole combination
Treatment:
Drug: Clomiphene Citrate and letrozole
group 2
Experimental group
Description:
letrozole alone
Treatment:
Drug: Clomiphene Citrate and letrozole

Trial contacts and locations

1

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Central trial contact

Rukhsana Shaheen Afzal, MBBS,FCPS; Tahira Jabeen, MBBS,FCPS

Data sourced from clinicaltrials.gov

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