Infertility, Polycystic Ovarian Syndrome
Conditions
Keywords
PCOS, Clomiphene citrate resistant, Gonadotropin, IVF
Brief summary
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).
Detailed 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.
Interventions
PROCEDUREIVF
Women will undergo one IVF cycle
DRUGGonadotropin
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol
Sponsors
Mohamed Sayed Abdelhafez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | 9 months | Number of live births divided by the number of women |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 6-8 weeks gestational age | Number of clinical pregnancies divided by the number of women |
| Multifetal pregnancy rate | 12 weeks gestational age | Number of multifetal pregnancies divided by the number of clinical pregnancies |
| Miscarriage rate | 12 weeks gestational age | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies |
| Incidence of early ovarian hyperstimulation syndrome (OHSS) | Within 9 days of final triggering of oocyte maturation | Incidence of OHSS within 9 days of final triggering of oocyte maturation |
Countries
Egypt
Outcome results
None listed