Addition of low doses of hCG in the rFSH stimulation of infertile women of older age who are undergoing IVF

A prospective, multicenter, double-blind, randomized, placebo-controlled, two-parallel groups Phase IIIb clinical study, to assess the efficacy and safety of adding low doses of hCG at a short IVF protocol with GnRH agonist and controlled ovular stimulation with recombinant FSH (rFSH) at the beginning of the follicular phase and during the whole stimulation period in infertile women of older age who are undergoing IVF, on the number of embryos to be transferred

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005208-24-GR

Enrollment

100

Registered

2017-05-05

Start date

2017-07-12

Completion date

Unknown

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility MedDRA version: 20.0 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Pregnyl Product Name: human Chorionic Gonadotropin, hCG Product Code: SUB01277MIG Pharmaceutical Form: Lyophilisate and solvent for solution for injection INN or Proposed INN: human Chorio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: between 35 and 40 years, 2. Normal menstrual cycle (cycle duration: 24-35 days), 3. Normal endocrine function (normal values of PRL and TSH, FSH = 15 IU/ml), 4. Transvaginal ultrasound without abnormal findings, 5. Medical history devoid of any finding, 6. Indication for IVF/ICSI (NICE, 2016) 7. 1st or 2nd IVF/ICSI cycle Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. ?ndocrine or metabolic diseases, e.g. PCO (S) 2. Presence of any uterine or endometrium pathology, 3. Pelvic inflammatory disease (PID), 4. Basic FSH levels > 15 IU / ml, 5. Previous ovaries surgical intervention, 6. BMI = 35 kg/m2, 7. Age: 40 years

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to investigate whether the addition of low doses of hCG in a short protocol IVF with GnRH and controlled ovular stimulation with rFSH from the beginning of the follicular phase up to the whole stimulation period, on infertile women of older age (35-40 yrs) undergoing IVF may enhance the number of embryos to be transferred Primary endpoint: the number of embryos to be transferred ;Secondary Objective: • The number of follicles (>11, >14, >18 mm) at the day of the follicles' triggering with hCG, • The endometrium thickness at the day of the follicles' triggering with hCG • The percentage of clinical pregnancies (existence of positive cardiac function at the 7th week of gestation in ultrasound) • The percentage of birth of living newborns • The percentage of automatic abortions (loss of pregnancy following a positive embryo cardiac function, after 12 weeks of gestation) • The percentage of continuing pregnancies (positive embryo cardiac function, after 12 weeks of gestation) • The percentage of the Ovarian HyperStimulation Syndrome (OHSS), following hCG triggering, during the next two weeks) • The percentage of multiple gestation. ;Primary end point(s): The number of (produced) embryos to be transferred ;Timepoint(s) of evaluation of this end point: 14-17 days following the initiation of the current IVF cycle	—

Measure

Time frame

Main Objective: The main objective of the study is to investigate whether the addition of low doses of hCG in a short protocol IVF with GnRH and controlled ovular stimulation with rFSH from the beginning of the follicular phase up to the whole stimulation period, on infertile women of older age (35-40 yrs) undergoing IVF may enhance the number of embryos to be transferred Primary endpoint: the number of embryos to be transferred ;Secondary Objective: • The number of follicles (>11, >14, >18 mm) at the day of the follicles' triggering with hCG, • The endometrium thickness at the day of the follicles' triggering with hCG • The percentage of clinical pregnancies (existence of positive cardiac function at the 7th week of gestation in ultrasound) • The percentage of birth of living newborns • The percentage of automatic abortions (loss of pregnancy following a positive embryo cardiac function, after 12 weeks of gestation) • The percentage of continuing pregnancies (positive embryo cardiac function, after 12 weeks of gestation) • The percentage of the Ovarian HyperStimulation Syndrome (OHSS), following hCG triggering, during the next two weeks) • The percentage of multiple gestation. ;Primary end point(s): The number of (produced) embryos to be transferred ;Timepoint(s) of evaluation of this end point: 14-17 days following the initiation of the current IVF cycle

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Secondary

Measure	Time frame
Secondary end point(s): • The number of follicles (>11, >14, >18 mm) at the day of follicles' triggering with hCG • The endometrium thickness at the day of follicles' triggering with hCG • The percentage of clinical pregnancies (existence of positive cardiac function at the 7th week of gestation in the ultrasound test) • The percentage of birth of living newborns • The percentage of automatic abortions (lost of pregnancy following a positive cardiac function at 20 weeks) • The percentage of continuing pregnancies (positive cardiac function after 12 weeks of gestation) • The percentage of the Ovarian HyperStimulation Syndrome (OHSS) (during the 2 weeks time following follicular triggering with hCG) • The percentage of multiple gestation. ;Timepoint(s) of evaluation of this end point: • At the day of follicles' triggering with hCG • At the day of follicles' triggering with hCG • At the 7th week of gestation • At 20 weeks of gestation • After 12 weeks of gestation) • The percentage of the Ovarian • 2 weeks following follicular triggering with hCG	—

Measure

Time frame

Secondary end point(s): • The number of follicles (>11, >14, >18 mm) at the day of follicles' triggering with hCG • The endometrium thickness at the day of follicles' triggering with hCG • The percentage of clinical pregnancies (existence of positive cardiac function at the 7th week of gestation in the ultrasound test) • The percentage of birth of living newborns • The percentage of automatic abortions (lost of pregnancy following a positive cardiac function at 20 weeks) • The percentage of continuing pregnancies (positive cardiac function after 12 weeks of gestation) • The percentage of the Ovarian HyperStimulation Syndrome (OHSS) (during the 2 weeks time following follicular triggering with hCG) • The percentage of multiple gestation. ;Timepoint(s) of evaluation of this end point: • At the day of follicles' triggering with hCG • At the day of follicles' triggering with hCG • At the 7th week of gestation • At 20 weeks of gestation • After 12 weeks of gestation) • The percentage of the Ovarian • 2 weeks following follicular triggering with hCG

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Countries

Greece

Contacts

Public ContactHarry Therianos

CORONIS Research

htherianos@coronis.gr+302108778 000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026