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IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

M

Mohamed Sayed Abdelhafez

Status and phase

Withdrawn
Phase 4

Conditions

Infertility
Polycystic Ovarian Syndrome

Treatments

Drug: Gonadotropin
Procedure: IVF

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Full description

Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Infertile women with PCOS as defined by the Rotterdam criteria.
  • CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion criteria

  • Age < 20 or > 35 years.
  • Presence of any infertility factor other than anovulatory PCOS.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
  • Metabolic or hormonal abnormalities.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

IVF group
Active Comparator group
Description:
Women will undergo one full IVF cycle
Treatment:
Procedure: IVF
Gonadotropin group
Active Comparator group
Description:
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
Treatment:
Drug: Gonadotropin

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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