GnRHa trigger: The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Pilot Study in Normo-responder IVF Patients

• Sponsor: Peter Humaidan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01980680
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 65
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: hCG; Drug: Progesterone and Estradiol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Agonist trigger Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)	Drug: hCG
Active Comparator: hCG hCG trigger Pregnyl (hCG) and Progesterone and Estradiol	Drug: Progesterone and Estradiol

Outcome Measures

Primary Outcome Measures

1. Ongoing pregnancy rate per patient [10th week of gestation.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age between 20 and 40

• Normal menstrual cycles: 25-34 days

• Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)

• BMI >18 and <35 kg/m2

Exclusion Criteria:

• Patients with >14 follicles on day of trigger

• Previous hyperresponse with OHSS development

• Previous low response (less than 3 oocytes on a high dose of FSH stimulation)

• Endocrine disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Fertility Clinic, Regional Hospital of Skive	Skive		Denmark	7800

Sponsors and Collaborators

• Peter Humaidan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Humaidan, Professor, Regionshospitalet Viborg, Skive
• ClinicalTrials.gov Identifier: NCT01980680
• Other Study ID Numbers: Agonist5
• First Posted: Nov 11, 2013
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Infertility; Estradiol; Progesterone

Study Results

No Results Posted as of Dec 17, 2020