Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

IVI Madrid

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Estradiol valerate; Drug: Levonorgestrel and ethinylestradiol

Study type: Interventional

Funder types: Other

Identifiers

NCT01501448

IVIMAD-GV-OCPE-2011

Details and patient eligibility

About

The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.

Enrollment: 118 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1st or 2nd IVF cycle
• BMI <30 kg/m2
• regular menstrual cycles
• basal FSH <10IU and E2 <60pg/mL

Exclusion criteria

• polycystic ovaries
• endometriosis
• previous ovarian surgery
• previous low ovarian response

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

OCP

Active Comparator group

Treatment:

Drug: Levonorgestrel and ethinylestradiol

Oral estradiol valerate

Active Comparator group

Treatment:

Drug: Estradiol valerate