GnRH Agonist Trigger and Modified Luteal Phase Support, A... | NCT02053779

Studies
GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Bolus of GnRHa at the Time of Implantation - a RCT

NCT02053779

Sponsor

Centre Hospitalier Universitaire Ibn Rochd

Status

Completed

Last Update Posted

Jul 21, 2017Actual

Enrollment

328Actual

Phase

Phase 3

Conditions

Infertility

Interventions

Triptorelin 0.1mg

Countries

Algeria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014Actual

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Jan 31, 2014

First Submission Date that Met QC Criteria

Feb 3, 2014

First Posted Date

Feb 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2017

Last Update Posted Date

Jul 21, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

benmachiche abdelhamid, Dr benmachiche abdelhamid, private infertility centre, Ibn rochd, constantine, Algeria, Centre Hospitalier Universitaire Ibn RochdPrincipal Investigator

Lead Sponsor

Centre Hospitalier Universitaire Ibn RochdOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.

Acronyms:

GnRH: gonadotropin-releasing hormone FSH: follicle stimulating hormone LH: luteinizing hormone HCG:human chorionic gonadotropin IVF:In vitro fertilization ICSI:intracytoplasmatic sperm injection OHSS:ovarian hyperstimulation syndrome OMEGA: oocyte maturation employing GnRH-agonist OPU: ovum pick up NaCl: sodium chloride

Detailed Description

It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.

Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

328Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GnRH-agonist	Experimental	Experimental Arm: Triptorelin 0.1 mg	Drug: Triptorelin 0.1mg
Control Arm	No Intervention	Control Arm: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Triptorelin 0.1mg	Drug	Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg followed by hCG 1500 iu the day of OPU.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
implantation rate	number of gestational sacs per number of embryos transferred	5 weeks after IVF/ICSI

Secondary Outcomes

Measure	Description	Time Frame
chemical pregnancy	confirmed by beta-hCG 14 days post embryo transfer	2 weeks after IVF/ICSI
clinical pregnancy	appearance of yolk sac with foetal heart beat at 7 weeks of gestation

Other Outcomes

Measure	Description	Time Frame
ovarian hyperstimulation syndrome OHSS	frequency of moderate to severe OHSS	from date of triggering until 2 weeks after pregnancy test

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female age < 40 years
Baseline FSH and LH < 12 IU/l.
Body Mass Index > 18 and < 35 kg/m2
No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities
Patients with at least one embryo at transfer time

Exclusion Criteria:

Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering).
Reduced ovarian reserve
Fertilization failure
Severe endocrinopathy
Azoospermia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Abdelhamid benmachiche, Doctor	Ibn roch infertility centre, cité boussouf, Constantine Algeria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ibn Rochd Infertility Centre		Constantine		25000	Algeria

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017329	Triptorelin Pamoate

Ancestor Terms

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided