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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01504139

Enrollment

Registered

2012-01-05

Start date

2012-01-31

Completion date

2014-08-31

Last updated

2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Progesterone Levels

Brief summary

Detailed 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.

Interventions

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

when the follicles are over 12 mm FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) is replaced by hCG (r-hCG, Ovitrelle,Merck-Serono, Hellerup,Denmark).

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

hCG(r-hCG,Ovitrelle,Merck-Serono, Hellerup, Denmark) is given together with FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) from the beginning of the FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark)stimulation.

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

LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.

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

The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Levels of progesterone in the mid-luteal phase.	up to 1-1½years.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 16, 2026