The Effect of Dual Trigger for Final Oocyte Maturation on IVF/ICSI Outcomes in Patients With Suboptimal Ovarian Response

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

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-11-30

Brief Summary

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Recently, in patients with a suboptimal ovarian response, a study of the role of adding a single dose of GnRH agonist to a standard dose of hCG to initiate final oocyte maturation has also been studied. Griffin et al. (2014) reported that in patients who had more than 25% immature oocytes in their previous IVF cycle, the use of dual stimulation could increase the number of mature oocytes. Since studies in this field are limited, the researchers decided to design a clinical trial to investigate the effect of adding a GnRH agonist to a standard dose of hCG to initiate final oocyte maturation in patients with a sub-optimal ovarian response.

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Detailed Description

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Ovulation stimulation will be performed in all patients with the Standard GnRH antagonist Protocol with E2 priming, with the antagonist protocol administered in all patients from the 20th cycle until the start of the next menstrual cycle with 4 mg of estradiol daily. Blood sampling (FSH, LH, and estradiol levels) will be performed on the second day of the menstrual cycle, just before gonadotropin stimulation. Ovarian stimulation will start from the second or third day of menstruation with a maximum dose of 225 units of rFSH (Gonal -F: Serono Laboratories Ltd, Geneva, Switzerland), and then if the follicle is observed, start with 13 injections of GnRH antagonist (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc)). From the seventh day of the cycle, the dose of rFSH will be determined according to the rate of ovarian response by vaginal ultrasonography two days in advance. If you see at least 2 follicles 18 mm in size or more, the antagonist will be injected. GnRH and gonadotropins (Gonal-F) will stop and (oocyte triggering) will be the final stimulation of oocyte maturation, at this time, the block randomization method will be designed to randomize allocation of patients into groups with blocks of size 4. Recently, in patients with a suboptimal ovarian response, a study of the role of adding a single dose of GnRH agonist to a standard dose of hCG to initiate final oocyte maturation has also been studied. Griffin et al. (2014) reported that in patients who had more than 25% immature oocytes in their previous IVF cycle, the use of dual stimulation could increase the number of mature oocytes. Since studies in this field are limited, the researchers decided to design a clinical trial to investigate the effect of adding a GnRH agonist to a standard dose of hCG to initiate final oocyte maturation in patients with a suboptimal ovarian response.

Controlled Ovulation stimulation (COS) will be performed in all patients with the Standard GnRH antagonist Protocol with E2 priming, with the antagonist protocol administered in all patients from the 20th cycle until the start of the next menstrual cycle with 4 mg of estradiol daily. Blood sampling (FSH, LH, and estradiol levels) will be performed on the second day of the menstrual cycle, just before gonadotropin stimulation. Ovarian stimulation will start from the second or third day of menstruation with a maximum dose of 225 units of rFSH (Gonal -F: Serono Laboratories Ltd, Geneva, Switzerland), and then if the follicle is observed, start with 13 injections of GnRH antagonist (Cetrotide®, 0.25 mg cetrorelix acetate, Serono, Inc)). From the seventh day of the cycle, the dose of rFSH will be determined according to the rate of ovarian response by vaginal ultrasonography two days in advance. If you see at least 2 follicles 18 mm in size or more, the antagonist will be injected. GnRH and gonadotropins (Gonal-F) will stop and (oocyte triggering) will be the final stimulation of oocyte maturation, at this time, the block randomization method will be designed to randomize allocation of patients into groups with blocks of size 4. The required number of blocks will be randomly selected according to sample size.

The final ovarian stimulation (oocyte triggering) will be performed in groups A and B as follows:

Group A (Experimental): 0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) associated with two ampoules of Ovitrelle (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be administered subcutaneously simultaneously.

Group B (Control): Two ampoules of Ovitrelle® (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be injected subcutaneously.

The COS cycles with less than two follicles will be cancelled s. Ovum pick up is performed 32-34 hours after oocyte triggering, and subsequently intracytoplasmic sperm injection (ICSI) /in-vitro fertilization (IVF) will be done for all the patients.

The main outcome measures are the number of dominant follicles (≥13 mm) on the day of hCG trigger and the number of mature (MII) oocytes collected after conventional versus delayed-start ovarian stimulation protocol. Secondary outcome measures are including total number of oocytes retrieved, oocyte maturity rate (number of MII oocytes/total number of oocytes), oocyte yield (total number of oocytes retrieved/ antral follicle count \[AFC\]), mature oocyte yield (number of mature oocytes retrieved/AFC), total dosage of gonadotropin (recombinant FSH and/or highly purified hMG) needed, number of days needed for ovarian stimulation, quality of obtained embryos, fertilization rate (the proportion of total number of two-pronuclear \[2PN\] stage zygotes /per total injected MII oocytes), implantation rate (total number of observed gestational sac/ number of transferred embryos) and clinical pregnancy rate (presence of fetal heart beat by transvaginal ultrasound per embryo transfer).

Conditions

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Ovarian Stimulation Reproductive Techniques, Assisted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A (Experimental oocyte triggering approach)

0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) associated with two ampoules of Ovitrelle (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be administered subcutaneously simultaneously for final oocyte triggering.

Group Type EXPERIMENTAL

Dual triggering

Intervention Type OTHER

Adding GnRH agonist (0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) to routine oocyte triggering (two ampoules of Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) is defined as dual triggering.

Group B (Routine oocyte triggering approach)

Two ampoules of Ovitrelle® (Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) will be injected subcutaneously for final oocyte triggering.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dual triggering

Adding GnRH agonist (0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) to routine oocyte triggering (two ampoules of Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) is defined as dual triggering.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients with poor ovarian response (POR) diagnosis according to the POSEIDON stratification system (as POSEIDON group 1) with following criteria :

* Women' age under 35 years;
* Previous unexpected poor or suboptimal ovarian response after using conventional protocols (subgroup 1a: \< 4 oocytes ) and (subgroup 1b: 4-9 oocytes retrieved)
* Adequate ovarian reserve (antral follicle count ≥5 on menstrual cycle day 2-3; and basal serum AMH ≥ 1.2 ng/ml)

Exclusion Criteria

* Ovarian failure including basal FSH above 20 IU/l or no antral follicle by ultrasound examination;
* Endometriosis grade 3 or higher;
* Severe male infertility (surgical sperm extraction: TESE, PESA)
* Body mass index \>30 kg/ m2
* History of uterine surgery as well as sub-mucosal and intramural fibroids greater than 5 cm or uterine polyps
* Treatment cycles with pre-implantation genetic diagnosis, blastocyst and donation embryo transfer indications
* Cigarette and drug addiction

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes