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Intracytoplasmic Sperm InjectionNCT05567731

Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve

A study testing ultrashort GnRHa, short GnRHa and long GnRHa in people with Intracytoplasmic Sperm Injection and GnRH Agonist, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to compare the gonadotropin-releasing hormone agonist (ultra-short) protocol versus (short and long) protocols on ovarian reserve in women undergoing intracytoplasmic sperm injection Read more about this study

Who is it for?
Ages 18 to 35 years, women only
What is being tested?
ultrashort GnRHa, short GnRHa and long GnRHa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
15 Oct 2022to 1 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • women
  • aged between 18- and 35-years old
  • undergoing Intracytoplasmic sperm injection.

Who cannot join

  • History of three or more previous In vitro fertilisation failures
  • Karyotypic abnormalities in either partner
  • Patients who previously undergo unilateral oophorectomy
  • Patients with chronic diseases (uncontrolled diabetes mellitus, cardiovascular diseases, liver and kidney failure)
  • Patients with diseases may affect In vitro fertilisation outcomes (Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases), polycystic ovary syndrome (PCOS) patients, poor responders (maternal age >40, Antral follicle counts (AFC)<5, Anti Mullerian Hormone (AMH)<1 and previous trial <5 oocyte retrieved)
  • Severe male factor, uterine abnormalities, adenomyosis and endometriosis
  • History of malignant tumors and related treatment, clinically significant systemic disease or abnormal hematology, chemistry, or urinalysis results at screening, non-ovarian causes (male or tubal factors with average ovarian reserve).

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Ahmed M.E. Ossman

    Tanta

Other trials in Egypt

About this study

Official title: Effect of Long, Short, and Ultrashort GnRH Agonist Treatment Protocols in Intracytoplasmic Sperm Injection Candidates on Ovarian Reserve

This study aimed to compare the gonadotropin-releasing hormone agonist (ultra-short) protocol versus (short and long) protocols on ovarian reserve in women undergoing intracytoplasmic sperm injection

Read the detailed description

Infertility affects about 15% of all the couples attempting to generate pregnancy, of which can be attributed to female and male factors. For females, advanced age and poor ovarian reserve were the main causes which resulted in infertility.

Pituitary down-regulation with gonadotropin-releasing hormone (GnRH) agonists followed by ovarian stimulation with exogenous gonadotropins has been successfully used as standard hormonal treatment in women undergoing assisted reproductive technologies (ART) for the last 10 years. Ovulation induction is a frequently utilized therapeutic procedure for the management of infertility.

With the use of gonadotropin-releasing hormone agonists in controlled ovarian hyperstimulation (COH) protocols, the results of the ART improved in terms of reduction in cycle cancellation by the almost abolition of spontaneous LH surges (<2%). The GnRHa also reduce inadequate follicular development and imprecise clinical pregnancy rate.

Intracytoplasmic sperm injection (ICSI), it has allowed successful pregnancies and proved to be a consistent treatment for the alleviation of infertility due to severe semen abnormalities including cryptozoospermia.

Being tested
ultrashort GnRHa, short GnRHa, long GnRHa
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrashort GnRHaDrug

    Also called ultrashort gonadotropin-releasing hormone (GnRH) agonist

    the patients used the ultrashort protocols with GnRH agonist (GnRH-a, and recombinant Follicle-Stimulating Hormone for controlled ovarian hyperstimulation (COH). Form the second day of menstrual cycle, 0.1 mg/d GnRHa will be injected by subcutaneous injection for 3-4 d.

    Gonadotropins will be added from the third day of menstrual cycle and the initial gonadotropin doses will be 225-300 IU/d. During the treatment, gonadotropin doses will be adjusted according to guided monitoring of follicle growth and measurement of serum estradiol (E2) levels of 10 000 units of human chorionic gonadotrophin (hCG) will be administered when 43 follicles will be 418 mm

  • short GnRHaDrug

    Also called short gonadotropin-releasing hormone (GnRH) agonist

    Buserelin acetate 100 mg five times daily and FSH will be started on the 2nd day of the menstrual cycle as short application. The dose of gonadotropin hormone will be individualized according to the patient's age and previous stimulation history or response to stimulation. Cycles will be monitored by transvaginal ultrasonography and serum estradiol (E2) levels.

    Follicular maturation will be completed by the administration of 10000 IU human chorionic gonadotrophin (hCG) when at least two follicles reached a diameter of >18 mm. Thirty-five to thirty-six hours after human chorionic gonadotrophin (hCG) administration, ovum retrieval will be performed by transvaginal echo-guided ovarian puncture.

  • long GnRHaDrug

    Also called long gonadotropin-releasing hormone (GnRH) agonist

    In the long protocol, daily subcutaneuous injection of Triptorelin :Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium < 5 mm and low estradiol (E2) < 50 and Luteinizing Hormone < 5IU/l with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300 IU/day according to women age, day 3 Follicle-Stimulating Hormone, Anti-Müllerian Hormone and previous gonadotropin response then adjustment of the dose according to ovarian response monitored by serum estradiol (E2) and ultrasound evaluation.

Study groups in NCT05567731
Study groupRoleWhat they receive
ultrashort GnRHaExperimentalthe patients used the ultrashort protocols with GnRH agonist (GnRH-a, and recombinant FSH for controlled ovarian hyperstimulation (COH). Form the second day of menstrual cycle, 0.1 mg/d GnRH agonist will be injected by subcutaneous injection for 3-4 d.
Receives: Drug: ultrashort GnRHa
short GnRHaExperimentalBuserelin acetate 100 mg five times daily and FSH will be started on the 2nd day of the menstrual cycle as short application. The dose of gonadotropin hormone will be individualized according to the patient's age and previous stimulation history or response to stimulation. Cycles will be monitored by transvaginal ultrasonography and serum E2 levels.
Receives: Drug: short GnRHa
long GnRHaExperimentalIn the long protocol, daily SC injection of Triptorelin :Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium < 5 mm and low E2 < 50 and LH < 5IU/l with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300 IU/day according to women age, day 3 FSH,AMH and previous gonadotropin response then adjustment of the dose according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day for folliculometry and endometrial thickness and pattern.
Receives: Drug: long GnRHa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancies

    Number of ongoing pregnancies per woman randomized, defined as evidence of a gestational sac with fetal heart motion at 12 weeks or later, confirmed with ultrasound.

    Measured: 12 weeks postintervention

Secondary outcomes (4)

  1. retrieved oocytes

    Number of oocytes retrieved per woman randomized

    Measured: 4 days postintervention

  2. Estradiol level

    Estradiol level will be recorded

    Measured: second day of menstruation

  3. Luteinizing Hormone level

    Luteinizing Hormone level will be recorded

    Measured: second day of menstruation

  4. Follicle-Stimulating Hormone level

    Follicle-Stimulating Hormone level will be recorded

    Measured: second day of menstruation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start15 Oct 2022
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05567731
Sponsor's protocol ID
35416/4/22
Status last verified
Dec 2023
First submitted
2 Oct 2022
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be available under a reasonable request from the corresponding author

Questions about this trial

What is this clinical trial studying?

A study testing ultrashort GnRHa, short GnRHa and long GnRHa in people with Intracytoplasmic Sperm Injection and GnRH Agonist, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancies (time frame: 12 weeks postintervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.

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