Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation

Peter Humaidan

Status and phase: Completed; Phase 4

Conditions: Frozen Embryo Transfer; Pregnancy Loss

Treatments: Drug: Estradiol and progeterone

Study type: Interventional

Funder types: Other

Identifiers

NCT01943812

Skive-2013-BA

Details and patient eligibility

About

The aim of this study is to compare two FET protocols by modifying the substituted FET cycle in order to maintain a higher ongoing positive pregnancy rate and thus reduce the early pregnancy loss.

Hypothesis: adding GnRH-agonist to the substituted cycle in FET treatment reduces the early pregnancy loss.

Enrollment: 287 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Endometrial thickness ≥ 7 mm after stimulation
• 18-45 years
• IVF/ICSI fertilisation
• BMI > 18,5 <30 kg/m2
• cycle length 25-34 days

Exclusion criteria

• endometrial thickness < 7 mm or no triple layer endometrium and/or functional follicles
• Uterine abnormality
• Chronic medical disease
• oocyte donation cycles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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287 participants in 2 patient groups

Substituted FET cycle and GnRHa

Experimental group

Description:

Substituted FET GnRH-a 2 bolus two days before Estradiol 6 mg Progesterone (Crinone) 180 mg

Treatment:

Drug: Estradiol and progeterone

Substituted FET cycle

Active Comparator group

Description:

substituted FET cycle Estradiol Progesterone

Treatment:

Drug: Estradiol and progeterone