Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

• Sponsor: AZ Jan Palfijn Gent (Other)
• Overall Status: Completed
• CT.gov ID: NCT01607203
• Collaborator: Onze Lieve Vrouw Hospital (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Decapeptyl Daily; Drug: pregnyl	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: hCG 5000 IU Pregnyl SC	Drug: pregnyl; 5000 IU SC
Active Comparator: hCG and GnRH agonist 5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC	Drug: Decapeptyl Daily; Decapeptyl 0.2 mg SC once 1day; Other Names: Gonapeptyl ; Drug: pregnyl; 5000 IU SC

Outcome Measures

Primary Outcome Measures

1. MII Oocytes [3 weeks]

   the number of mature oocytes retrieved

Secondary Outcome Measures

1. Pregnancy Rate [12 weeks]

   the number of pregnancies obtained, wich still is the most important issue for the patients

2. Patients With Cryopreserved Embryos [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Intra-cytoplasmic sperm injection (ICSI) patients below 38 years

• 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

• polycystic ovary syndrome (PCOS) patients

• patients with endocrinological diseases or problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A Z Jan Palfijn	Gent	Oost-vlaanderen	Belgium	9000

Sponsors and Collaborators

• AZ Jan Palfijn Gent
• Onze Lieve Vrouw Hospital

Investigators

• Principal Investigator: Wim Decleer, gynacologist, IVF Centrum Jan Palfijn Gent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Decleer Wim, gynaecologist, AZ Jan Palfijn Gent
• ClinicalTrials.gov Identifier: NCT01607203
• Other Study ID Numbers: Dr. Decleer Wim
• First Posted: May 30, 2012
• Last Update Posted: Feb 19, 2015
• Last Verified: Feb 1, 2015

• Keywords provided by Dr. Decleer Wim, gynaecologist, AZ Jan Palfijn Gent: ovarian hyper stimulation syndrome (OHSS); metaphase II oocytes (MII); good quality embryo's; implantation; pregnancy
• Additional relevant MeSH terms: Infertility; Triptorelin Pamoate; Chorionic Gonadotropin

Study Results

Participant Flow

Pre-assignment Detail	the Principal Investigator (PI) prescreened the patients and only the eligible patients were assigned to a group by the study coordinator

Arm/Group Title	hCG Triggering	hCG and GnRH Agonist Triggering
Arm/Group Description	TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Period Title: Overall Study
STARTED	59	61
COMPLETED	59	61
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	HCG TRIGGERING	hCG and GnRH Agonist Triggering	Total
Arm/Group Description	TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL	Total of all reporting groups
Overall Participants	59	61	120
Age (YEARS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [YEARS]	30.5 (4.1)	30.0 (3.6)	30.2 (3.8)
Sex: Female, Male (Count of Participants)
Female	59 100%	61 100%	120 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Belgium	59 100%	61 100%	120 100%
Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23.5 (5.1)	23.8 (4.6)	23.7 (4.8)

Outcome Measures

1. Primary Outcome

Title	MII Oocytes
Description	the number of mature oocytes retrieved
Time Frame	3 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hCG TRIGGERING	hCG and GnRH Agonist Triggering
Arm/Group Description	TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Measure Participants	59	61
Mean (Standard Deviation) [cumulus oocyte complex]	9.2 (6.7)	10.3 (6.8)

2. Secondary Outcome

Title	Pregnancy Rate
Description	the number of pregnancies obtained, wich still is the most important issue for the patients
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hCG Triggering	hCG and GnRH Agonist Triggering
Arm/Group Description	TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Measure Participants	59	61
Number [pregnancies]	28	45

3. Secondary Outcome

Title	Patients With Cryopreserved Embryos
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	hCG Triggering	hCG and GnRH Agonist Triggering
Arm/Group Description	TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL	DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
Measure Participants	59	61
Number [patients with cryopreserved embryos]	21	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	hCG TRIGGERING, hCG and GnRH Agonist Triggering
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	t -test
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	Fisher Exact
	Comments

Adverse Events

Arm/Group Title	hCG TRIGGERING		hCG and GnRH Agonist Triggering
Arm/Group Description	TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL		DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
All Cause Mortality
	hCG TRIGGERING		hCG and GnRH Agonist Triggering
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	hCG TRIGGERING		hCG and GnRH Agonist Triggering
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	hCG TRIGGERING		hCG and GnRH Agonist Triggering
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/61 (0%)
Metabolism and nutrition disorders
OHSS	0/59 (0%)	0	0/61 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.