The Luteal Phase After GnRHa Trigger - a Proof of Concept Study

Regionshospitalet Viborg, Skive

Status and phase: Completed; Phase 4

Conditions: Infertility; Progesterone Levels

Treatments: Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase; Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase; Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase; Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase

Study type: Interventional

Funder types: Other

Identifiers

NCT01504139

M-20110289

Details and patient eligibility

About

The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.

Full description

The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation. Furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hCG without the administration of exogenous P, while maintaining good reproductive outcome.

Enrollment: 93 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women from the age of 25 up to 40
• Serum-FSH and serum-LH levels under 12 IU/L
• Length of period between 25 and 34 days
• BMI between 18 and 30

Exclusion criteria

• less than 2 ovaries
• uterine abnormalities
• PCOS or UL-PCO (more than 11 follicles over 12 mm in 1 ovary

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 4 patient groups

hCG in the late follicular phase + luteal phase

Experimental group

Treatment:

Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase

hCG in the follicular phase + luteal phase

Experimental group

Treatment:

Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase

LH in the luteal phase

Experimental group

Treatment:

Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase

vaginal progesterone and estradiol in the luteal phase

Active Comparator group

Treatment:

Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase