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
|Condition or disease||Intervention/treatment||Phase|
|HCG; IVF; Pregnancy Rates; ART; Chorionic Gonadotropin||Drug: hCG Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
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
100IU per day containing N/S 0.9% will be injected
- The rate of clinical pregnancy [ Time Frame: 7 weeks after the initiation of treatment ]Positive heart rate at 7 weeks of gestation in ultrasound
- Number of follicles [ Time Frame: 2 weeks after the initiation of treatment ](> 11,> 14,> 18 mm) on the day of triggering with hCG
- The thickness of the endometrium [ Time Frame: 2 weeks after the initiation of treatment ]On the day of follicular maturation (triggering) with hCG
- 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
- 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
- The percentage of ovarian hyperstimulation syndrome [ Time Frame: 2 weeks after the hCG triggering ]After triggering with hCG
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
|Contact: Siristatidis||5822237 ext 0030 firstname.lastname@example.org|
|3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit||Recruiting|
|Athens, Chaidari, Greece, 12462|
|Contact: Charalampos Siristatidis, Ass Prof 5832283 ext 0030 210 email@example.com|
|Sub-Investigator: Petros Drakakis, Ass Prof|
|Sub-Investigator: Konstantinos Dafopoulos, Prof|
|Sub-Investigator: Basil Tarlatzis, Prof|
|Principal Investigator:||Charalampos Siristatidis, Ass Prof||National and Kapodistrian University of Athens|