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

NCT03423537 | Terminated Phase 3 DMC

• 2 other identifiers: hCG-GR-001-20162016-005208-24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

HCG; IVF; Pregnancy Rates; ART; Chorionic Gonadotropin

Outcome Measures

Primary Outcomes (2)

• number of transferred embryos

  number of high quality transferred embryos at day 3

  21 days after the beginning of ovarian stimulation

• The rate of clinical pregnancy

  Positive heart rate at 7 weeks of gestation in ultrasound

  7 weeks after the initiation of treatment

Secondary Outcomes (4)

• Number of follicles

  2 weeks after the initiation of treatment

• The thickness of the endometrium

  2 weeks after the initiation of treatment

• Automatic abortion rates - miscarriage

  up to 20 weeks of gestation

• The percentage of ovarian hyperstimulation syndrome

  2 weeks after the hCG triggering

Study Arms (2)

Group 1 [HCG (+) group]

EXPERIMENTAL

"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

Group 2 [placebo]

PLACEBO COMPARATOR

"Group 2" will indicate the application of the standard GnRH agonist protocol without the addition of hCG, but placebo, instead

Drug: Placebo

Interventions

hCG DRUG

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.

Also known as: Pregnyl

Group 1 [HCG (+) group]

Placebo DRUG

100IU per day containing N/S 0.9% will be injected

Group 2 [placebo]

Eligibility Criteria

• Age: 35 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Endocrine or metabolic disorders, e.g. PCO (S)
• Pathology of the uterus and / or endometrium,
• Pelvic inflammatory disease (PID),
• Basal FSH levels\> 15 IU / ml,
• Surgery in the ovaries,
• Body Mass Index (BMI) ≥ 35 kg / m2,
• Age: \<35 years \&\> 41 years old

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• University of Thessaly: collaborator

Study Sites (1)

3rd Department of Obstetrics and Gynecology, Assisted Reproduction Unit

Athens, Chaidari, 12462, Greece

Location

Related Publications (4)

• Drakakis P, Loutradis D, Beloukas A, Sypsa V, Anastasiadou V, Kalofolias G, Arabatzi H, Kiapekou E, Stefanidis K, Paraskevis D, Makrigiannakis A, Hatzakis A, Antsaklis A. Early hCG addition to rFSH for ovarian stimulation in IVF provides better results and the cDNA copies of the hCG receptor may be an indicator of successful stimulation. Reprod Biol Endocrinol. 2009 Oct 13;7:110. doi: 10.1186/1477-7827-7-110.

  PMID: 19825188 RESULT

• Gomaa H, Casper RF, Esfandiari N, Chang P, Bentov Y. Addition of low dose hCG to rFSh benefits older women during ovarian stimulation for IVF. Reprod Biol Endocrinol. 2012 Aug 6;10:55. doi: 10.1186/1477-7827-10-55.

  PMID: 22866896 RESULT

• Martins WP, Vieira AD, Figueiredo JB, Nastri CO. FSH replaced by low-dose hCG in the late follicular phase versus continued FSH for assisted reproductive techniques. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD010042. doi: 10.1002/14651858.CD010042.pub2.

  PMID: 23543584 RESULT

• Beretsos P, Partsinevelos GA, Arabatzi E, Drakakis P, Mavrogianni D, Anagnostou E, Stefanidis K, Antsaklis A, Loutradis D. "hCG priming" effect in controlled ovarian stimulation through a long protocol. Reprod Biol Endocrinol. 2009 Aug 31;7:91. doi: 10.1186/1477-7827-7-91.

  PMID: 19719843 RESULT

Related Links

• Current guidelines

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Charalampos Siristatidis, Ass Prof

  National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: February 6, 2018
• Study Start: June 1, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 30, 2021

Record last verified: 2020-09

Locations

GR (1)