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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Female Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Prospective cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Single

Study Groups

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Clomiphene Citrate (CC)/r-FSH

Administration of 100mg/day Clomiphene citrate (CC) from day 3 to day 7 of the cycle (5 days) in combination with low-dose gonadotropins (150IU) according to a short stimulation GnRh antagonists protocol.

Treatment schedule:

Serum AMH levels were measured before the stimulation began. Estradiol and FSH levels were measured on the third day of the participants' menstrual cycle. Ovarian stimulation started on the same day with 150 IU of recombinant human Follicle-Stimulating Hormone (r-FSH) after a transvaginal ultrasound was performed, provided that serum FSH levels were below 16 mIU/ml and estradiol levels were under 70 pg/ml (r-FSH group). All patients underwent routine monitoring with transvaginal ultrasound. The GnRH antagonist cetrorelix acetate, at a dose of 0.25 mg/day was given when a dominant follicle reached 14 mm in diameter. Oocyte retrieval (OPU) was performed 34-36 hours after hCG administration followed by IVF/ICSI and embryo transfer on day 3 after OPU

Group Type ACTIVE_COMPARATOR

Clomiphane citrate

Intervention Type DRUG

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))

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

Intervention Type DRUG

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)

High-dose Gonadotropins (r-FSH)

Patients in this group will be stimulated according to the high-dose short r-FSH antagonist protocol.

Treatment schedule:

Ovarian stimulation started on day 3 with 300 IU of recombinant human Follicle-Stimulating Hormone (r-FSH) after a transvaginal ultrasound was performed, provided that serum FSH levels were below 16 mIU/ml and estradiol levels were under 70 pg/ml (r-FSH group). All patients underwent routine monitoring with transvaginal ultrasound and serum estradiol measurements. The GnRH antagonist cetrorelix acetate, at a dose of 0.25 mg/day, was given when a dominant follicle reached 14 mm in diameter. Oocyte retrieval (OPU) was performed 34-36 hours after hCG administration, followed by IVF/ICSI and embryo transfer on day 3 after OPU.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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)

Interventions

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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))

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Clomiphene citrate 50mg/tab Serpafar 50mg/tab Gonal-f 150 Iu/day Gonal-f 300 IU/day

Eligibility Criteria

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Inclusion Criteria

* 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).