Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02330770
Recruitment Status : Recruiting
First Posted : January 5, 2015
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mohamed Sayed Abdelhafez, Mansoura University

Brief Summary:
Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG

Condition or disease Intervention/treatment Phase
Infertility Drug: GnRHa and HCG Drug: GnRHa then HCG (single low-dose) Drug: GnRHa then HCG (multiple low-doses) Phase 4

Detailed Description:
The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry). When there will be at least 3 leading follicles > 18 mm in diameter, women will be randomized into 3 groups; group A (dual trigger group), group B (single low-dose HCG group) and group C (multiple low-doses HCG group). In group A, final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM. In group B, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will by administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval). In group C, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval. In all women, oocyte retrieval will be performed 34-36 hours after trigger and endometrial preparation for embryo transfer (ET) will be started on the day of oocyte retrieval by giving 400 mg vaginal natural progesterone supplement once daily plus 4 mg oral estradiol valerate once daily.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Dual Trigger Versus Gonadotropin Releasing Hormone Agonist Trigger Combined With Luteal Human Chorionic Gonadotropin Administration
Study Start Date : January 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dual trigger group
Trigger with concomitant GnRHa and HCG (single low-dose) administration
Drug: GnRHa and HCG
Final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM
Other Name: Decapeptyl and Pregnyl

Active Comparator: Single low-dose HCG group
Trigger with GnRHa then HCG (single low-dose) administration in luteal phase
Drug: GnRHa then HCG (single low-dose)
Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will be administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval)
Other Name: Decapeptyl then Pregnyl

Active Comparator: Multiple low-doses HCG group
Trigger with GnRHa then HCG (multiple low-doses) administration in luteal phase
Drug: GnRHa then HCG (multiple low-doses)
Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval
Other Name: Decapeptyl then Pregnyl




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 6 weeks after embryo transfer ]
    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures


Secondary Outcome Measures :
  1. Oocyte maturation rate [ Time Frame: On day of oocyte retrieval ]
    Number of mature oocytes divided by the number of retrieved oocytes

  2. Incidence of early OHSS [ Time Frame: Within 9 days of final triggering of oocyte maturation ]
    Incidence of OHSS within 9 days of final triggering of oocyte maturation

  3. Implantation rate [ Time Frame: 6 weeks after embryo transfer ]
    Number of gestational sacs on TVS scan at 4-6 weeks after ET divided by the number of transferred embryos

  4. Miscarriage rate [ Time Frame: 12 weeks gestational age ]
    Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
  • Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) > 14 in both ovaries; 4) basal serum AMH level > 3.36 ng/ml; 5) > 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level > 3000 pg/ml on the day of triggering of oocyte maturation.

Exclusion Criteria:

  • Age < 20 years or > 35 years.
  • BMI < 19 kg/m2 or > 35 kg/m2.
  • Moderate or severe endometriosis.
  • Hydrosalpinx.
  • Uterine abnormalities or myoma.
  • Previous uterine surgery.
  • Use of alternative techniques to minimize the risk of OHSS.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330770


Contacts
Layout table for location contacts
Contact: Mohamed S Abdelhafez, Dr +201144523366 msabdelhafez@gmail.com

Locations
Layout table for location information
Egypt
Fertility Care Unit (FCU) in Mansoura University Hospital Recruiting
Mansourah, Dakahlia, Egypt, 35111
Contact: Mohamed S Abdelhafez, Dr    +201144523366    msabdelhafez@gmail.com   
Private fertility care centers Recruiting
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
Layout table for investigator information
Principal Investigator: Mohamed S Abdelhafez, Dr Mansoura University
Study Director: Waleed El-refaie, Dr Port Said University
Study Chair: Ahmed Badawy, Prof Mansoura University

Layout table for additonal information
Responsible Party: Mohamed Sayed Abdelhafez, Dr, Mansoura University
ClinicalTrials.gov Identifier: NCT02330770     History of Changes
Other Study ID Numbers: MSA5
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Mohamed Sayed Abdelhafez, Mansoura University:
GnRHa trigger
Luteal phase support
OHSS
Additional relevant MeSH terms:
Layout table for MeSH terms
Chorionic Gonadotropin
Infertility
Genital Diseases, Male
Genital Diseases, Female
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents