Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovaries

Treatments: Drug: clomiphene citrate; Drug: phytoestrogen; Drug: estradiol valerate

Study type: Interventional

Funder types: Other

Identifiers

NCT02352597

222

Details and patient eligibility

About

Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Full description

Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Enrollment: 150 patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.

Exclusion criteria

women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 3 patient groups

clomiphene citrate

Active Comparator group

Description:

only50 mg orally every 8 hours started from cycle day 3 for 5 days

Treatment:

Drug: clomiphene citrate

estradiol valerate and CC

Active Comparator group

Description:

2mg estradiol valerate orally daily from cycle day 7 - 11 in addition to CC

Treatment:

Drug: estradiol valerate

Drug: clomiphene citrate

Phytoestrogen and CC

Active Comparator group

Description:

20mg of cimifuga racemosaorally from day 1- 12) in addition to CC

Treatment:

Drug: phytoestrogen

Drug: clomiphene citrate