Current partner codePEPTIDESDE
NCT06778733·Early Phase 1·INTERVENTIONAL

Effectiveness of Low Dose Gonadotropin Stimulation Protocol Vs High Dose Gonadotropin Protocol in Poor Responders

Status

Completed

Phase

Early Phase 1

Enrollment

22

Locations

2

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

In the present study we examined the effect of addition of CC to a low dose gonadotropin (150 IU/day) / GnRH antagonist protocol in comparison to a high gonadotropin dose (300 IU/day) regiment (short protocol) in women with poor ovarian responce (POR).

Full detailed description

22 patients diagnosed with poor ovarian response, aged 35-43 years, were enrolled in the study. The definition of poor response was based on the presence of at least one of the following criteria: Age equal or over 40 years old or other cause of subfertility, AFC less than 5-7, AMH 0.5-1,1ng/ml , a previous POR (≤3 oocytes with a conventional stimulation protocol or cancellation due to poor response) . All patients received appropriate counselling . Early follicular phase FSH and estradiol (E2) were measured prior to the initiation of treatment. All women had measurements of serum FSH and estradiol and a pelvic sonogram on the second day of their cycle. Providing that serum FSH level was less than 16 mIU/ml and estradiol level less than 70 pg/ml on cycle day2 , ovarian stimulation was initiated with 300 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of recombinant FSH and recombinant LH. All patients were re-evaluated on day 5 of the stimulation, and dosage adjustments were made and the antagonists (Cetrorelix or ganirelix 0.25 mg/day) were initiated when at least one follicle reached a diameter of 14mm . When at least 2 follicles reached an average diameter of 18 mm, final oocyte maturation was triggered with 10,000IU of hCG ( Ovitrelle, Greece Inc.). Oocyte retrieval was performed 34 to 36 hours later. All patients underwent ICSI. Patients with successful fertilization underwent embryo transfer under sonographic guidance on day 5 after retrieval. Serum β-hCG levels were measured 12 days after oocyte retrieval, and clinical pregnancy was confirmed by transvaginal ultrasound 14 days later. Ongoing pregnancy was confirmed at 12 weeks by ultrasound. In case of negative pregnancy test result the same participants received CC (100 mg/day) from day 3 to day 7 of the menstrual cycle, in combination with low-dose gonadotropins (150 IU/day) until the day of hCG administration. The primary outcome measure was ongoing pregnancy rates. Secondary outcomes included the number of follicles, the number of mature oocytes, fertilization rate, total number of embryos and embryo quality in each group. Furthermore, we included biochemical pregnancy rates and miscarriage as secondary outcomes as well.

Interventions

Treatment arms and agents.

DRUG

Clomiphane citrate

Clomiphene citrate 100mg/day from day 3 to day 7 of the cycle (5 days) will be added to the low-dose (150 IU) short GnRh antagonist protocol (recombinant human Follicle-Stimulating Hormone (r-FSH-alfa) (Gonal-f; Merck Serono Hellas AE))

DRUG

recombinant human Follicle-Stimulating Hormone (r-FSH-alfa)

All patients will undergo ovarian stimulation with the standard-dose GNRH-antagonist protocol. Ovarian stimulation will be initiated with 150 IU of of recombinant human Follicle-Stimulating Hormone (r-FSH-alfa) (Gonal-f; Merck Serono Hellas AE)

Timeline

From registration to results.

  1. First posted

    Jan 16, 2025

  2. Study start

    Jan 1, 2022

  3. Primary completion

    Jan 1, 2024

  4. Study completion

    Apr 30, 2024

  5. Results posted

    Not reported

  6. Registry updated

    Jan 16, 2025

Outcomes

What the study measures.

Primary outcomes

Ongoing pregnancy rates

Time frame · 28 months from start of study

succesfull clinical pregnancy after performing ultrasound on 12 weeks of pregnancy

Secondary outcomes

Number of follicles

Time frame · 24 months from start of study

Calculated on the day of triggering

Number of mature oocytes

Time frame · 24 months from start of study

MII

Fertilization rate

Time frame · 24 months from start of study

Percentage

Total number of embryos in each group

Time frame · 24 months from start of study

Total number of embryos

Biochemical pregnancy rates

Time frame · 24 months from start of study

Absence of clinical pregnancy

Miscarriage rates

Time frame · 28 months from start of study

Percentage of pregnancies that did not reach viability

Eligibility

Who can take part.

Minimum age
30 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
Yes

The inclusion criteria, established by the European Society of Human Reproduction and Embryology (ESHRE), define POR as the presence of at least two of the following features, had to be met: * Advanced maternal age (≥40 years) or any other risk factor for POR * A previous POR (≤3 oocytes with a conventional stimulation protocol) * An abnormal ovarian reserve test (Day 3 follicle-stimulating hormone (FSH) \> 12 mIU/ml * Anti-Müllerian hormone (AMH) \< 2ng/ml). Exclusion Criteria: The succesful ongoing pregnancy after the first stimulation.

Study locations

2 registered sites.

Greece. Showing up to 24 locations stored in the fast local snapshot.

Aretaieion University Hospital

Athens, Attica, Greece

Aretaieion University Hospital

Athens, Greece

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

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