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Low-dose HCG as an Adjunct to Ovarian Stimulation in Subfertile Women Undergoing ART (HCG)

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ClinicalTrials.gov Identifier: NCT03423537
Recruitment Status : Recruiting
First Posted : February 6, 2018
Last Update Posted : May 27, 2019
Sponsor:
Collaborators:
Aristotle University Of Thessaloniki
University of Thessaly
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

Brief Summary:
The objective of this prospective randomized clinical trial is to investigate whether the addition of low-dose hCG to a short GnRH-agonist protocol for IVF and ovarian stimulation with rFSH from the onset of the follicular phase and throughout stimulation in sub fertile women undergoing IVF, improves pregnancy rates.

Condition or disease Intervention/treatment Phase
HCG; IVF; Pregnancy Rates; ART; Chorionic Gonadotropin Drug: hCG Drug: Placebo Phase 3

Detailed Description:

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, two parallel group of patients, Phase IIIb clinical study to test the efficacy and safety of adding low-dose hCGs in a short protocol with GnRH agonist and ovarian stimulation with recombinant FSH (rFSH) from the onset of the follicular phase and throughout the duration of stimulation in enrolled women to the increase in the rate of clinical pregnancies.

Main end point will be the rate of clinical pregnancy (positive heart rate at 7 weeks of gestation in the ultrasound), while secondary endpoints will be

  • The number of follicles (> 11,> 14,> 18 mm) on the day of triggering with hCG
  • The thickness of the endometrium on the day of follicular maturation
  • Live birth rates
  • Automatic abortion rates (loss of pregnancy after positive heart function up to 20 weeks of gestation)
  • The rate of ongoing pregnancy (positive heart function after 12 weeks of gestation),
  • The percentage of ovarian hyperstimulation syndrome (after triggering) with hCG for the next 2 weeks
  • The rate of multiple pregnancy.

Participants will be randomly divided into two groups: the intervention group (Group 1) and the control group (Group 2). Randomization will be done using sealed envelopes marked "Group 1" and "Group 2". The randomization list will be prepared centrally for the four participating clinics (research centers) and there will be a "stratification" per center, per 30, respectively, and will be shared among the participants.

"Group 1" will indicate the application of the protocol by adding hCG with the initiation of controlled ovarian stimulation protocol for IVF / ICSI with rFSH, and "Group 2" will indicate the application of the conventional protocol without the addition of hCG .

Each patient's assignment to a treatment group will be made by calling the unit's midwife who will have 2 envelopes with the above indications and who will not be present when the pair is informed by 2 members of the research team.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Double-blind, Placebo-controlled, Phase III Clinical Study, on the Efficacy and Safety of Low-dose hCG in a Short Protocol With GnRH Agonist and Ovarian Stimulation With Recombinant FSH (rFSH) During the Follicular Phase in Subfertile Women Undergoing ART
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1 [HCG (+) group]
"Group 1" will indicate the application of the protocol by adding hCG with the initiation of standard GnRH agonist protocol for IVF / ICSI with rFSH
Drug: hCG
the addition of hCG (Pregnyl®, MSD Greece) will begin with the administration of gonadotrophin at a dose of 100 IU per day, administered subcutaneously, and will continue until the administration of hCG for follicular maturation.
Other Name: Pregnyl

Placebo Comparator: Group 2 [placebo]
"Group 2" will indicate the application of the standard GnRH agonist protocol without the addition of hCG, but placebo, instead
Drug: Placebo
100IU per day containing N/S 0.9% will be injected




Primary Outcome Measures :
  1. The rate of clinical pregnancy [ Time Frame: 7 weeks after the initiation of treatment ]
    Positive heart rate at 7 weeks of gestation in ultrasound


Secondary Outcome Measures :
  1. Number of follicles [ Time Frame: 2 weeks after the initiation of treatment ]
    (> 11,> 14,> 18 mm) on the day of triggering with hCG

  2. The thickness of the endometrium [ Time Frame: 2 weeks after the initiation of treatment ]
    On the day of follicular maturation (triggering) with hCG

  3. Live birth rates [ Time Frame: After the 20th week after the initiation of treatment, in case of pregnancy ]
    Birth after the 20th week of gestation

  4. Automatic abortion rates - miscarriage [ Time Frame: up to 20 weeks of gestation ]
    (Lss of pregnancy after positive heart function up to 20 weeks of gestation

  5. The percentage of ovarian hyperstimulation syndrome [ Time Frame: 2 weeks after the hCG triggering ]
    After triggering with hCG



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Ages Eligible for Study:   35 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age: between 35 and 40 years of age,
  2. Physiological menstrual cycles (24-35 day cycle),
  3. Normal endocrine function (normal PRL and TSH, FSH ≤ 15 IU / ml),
  4. Transvaginal ultrasound (TVS) without pathological findings,
  5. Free personal medical history,
  6. Indication for IVF / ICSI (NICE, 2016)
  7. 1st or 2nd IVF / ICSI cycle

Exclusion Criteria:

  1. Endocrine or metabolic disorders, e.g. PCO (S)
  2. Pathology of the uterus and / or endometrium,
  3. Pelvic inflammatory disease (PID),
  4. Basal FSH levels> 15 IU / ml,
  5. Surgery in the ovaries,
  6. Body Mass Index (BMI) ≥ 35 kg / m2,
  7. Age: <35 years &> 40 years old

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): NCT03423537


Contacts
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Contact: Siristatidis 5822237 ext 0030 210 harrysiri@yahoo.gr

Locations
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Greece
3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit Recruiting
Athens, Chaidari, Greece, 12462
Contact: Charalampos Siristatidis, Ass Prof    5832283 ext 0030 210    harrysiri@yahoo.gr   
Sub-Investigator: Petros Drakakis, Ass Prof         
Sub-Investigator: Konstantinos Dafopoulos, Prof         
Sub-Investigator: Basil Tarlatzis, Prof         
Sponsors and Collaborators
National and Kapodistrian University of Athens
Aristotle University Of Thessaloniki
University of Thessaly
Investigators
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Principal Investigator: Charalampos Siristatidis, Ass Prof National and Kapodistrian University of Athens

Additional Information:
Publications of Results:
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Responsible Party: Siristatidis Charalampos, MD, PhD, Associate Professor in Obstetrics and Gynecology, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT03423537     History of Changes
Other Study ID Numbers: hCG-GR-001-2016
2016-005208-24 ( EudraCT Number )
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: May 27, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Deslorelin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Reproductive Control Agents
Physiological Effects of Drugs