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AzTrials

Female InfertilityPhase 4NCT05286554

Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support

A Phase 4 study testing gonadotropin releasing hormone-agonist and Progesterone in people with Female Infertility, run by Alexandria 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

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Read more about this study

Who is it for?
Ages 20 to 38 years, women only
Conditions the study is for
Female Infertility
What is being tested?
gonadotropin releasing hormone-agonist and Progesterone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
17 Mar 2022to 18 Jan 2024
Phase
Phase 4
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 20 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient age ≤ 38 years.
  • BMI ≤ 30.
  • Basal follicle stimulating hormone (FSH) level ≤ 10 IU/L.
  • Anti-Müllerian hormone (AMH): ≤ 5 ng/ml.

Who cannot join

  • Endometriosis.
  • Polycystic ovarian syndrome (PCOS).
  • Uterine pathology or anomaly.
  • Evidence of hydrosalpinx by hysterosalpingography or ultrasound.
  • Comorbidities: Diabetes mellitus, hypertension, immune diseases.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Alexandria University

    Alexandria, Alexandria Governorate, 21526

Other trials in Egypt

About this study

Official title: Impact of Addition of Gonadotropin Releasing Hormone Agonist to Luteal Phase Support on Antagonist ICSI Cycles

Hormonal milieu during implantation is crucial to embryo-endometrium interaction and to the viability of the conceptus. Alterations in the peri-implantation environment are considered to impair perinatal outcomes in intracytoplasmic sperm injection (ICSI) therapy. GnRH-a is a new and promising modality for LPS. Regimens for using GnRH-a in LPS, including single mid-luteal bolus or the addition of a GnRH-a to progesterone supplementation, have been recently suggested. The aim of this study is to evaluate the impact of addition of mid-luteal single-dose or multiple-dose GnRH agonist to the routine luteal phase support in patients undergoing ICSI cycles using GnRH antagonist protocol.

Being tested
gonadotropin releasing hormone-agonist, Progesterone
Keywords
luteal phase support, ICSI, gonadotropin releasing hormone agonist
Medical subject headings
Infertility, Female

What participants receive

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

  • gonadotropin releasing hormone-agonistDrug

    Also called triptorelin 0.1 mg

    subcutaneous injection

  • ProgesteroneDrug

    Also called cyclogest

    vaginal suppositories (400 mg twice daily) starting on the day after oocyte retrieval and will be continued till pregnancy assessed by serum β-HCG 15 days after ICSI, and if pregnant, for 10 weeks of gestation.

Study groups in NCT05286554
Study groupRoleWhat they receive
Group 1ExperimentalWill receive routine LPS and additional single GnRH-a bolus, triptorelin 0.1 mg subcutaneous injection on the 6th day after oocyte retrieval.
Receives: Drug: gonadotropin releasing hormone-agonist; Drug: Progesterone
Group 2ExperimentalWill receive routine LPS and additional multiple mid-luteal GnRH-a, triptorelin 0.1 mg subcutaneous injection on the 5th, 7th and 9th days after oocyte retrieval.
Receives: Drug: gonadotropin releasing hormone-agonist; Drug: Progesterone
Group 3 (Control)Active comparatorWill receive the routine LPS without GnRH-a
Receives: Drug: Progesterone

What is being measured

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

  1. Clinical pregnancy rate

    Calculated as the number of clinical pregnancies (Presence of an intrauterine gestational sac with embryonic cardiac activity observed by vaginal ultrasound) divided by the number of embryo transfer procedures.

    Measured: 2 weeks after positive pregnancy test

Secondary outcomes (3)

  1. Implantation rate

    the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred.

    Measured: 2 weeks after positive pregnancy test

  2. Multiple pregnancy rate

    The percentage of pregnancies with more than one fetus

    Measured: 8 weeks of gestation

  3. Serum β-human chorionic gonadotropin (β-HCG) concentration

    In milli-International unit/ml on day 15 after ICSI

    Measured: 15 days after ICSI

Timeline

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

  1. First posted18 Mar 2022
  2. Study start17 Mar 2022
  3. Primary completion27 Oct 2023
  4. Study completion18 Jan 2024

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286554
Sponsor's protocol ID
0201599
Status last verified
Mar 2022
First submitted
10 Mar 2022
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • de Ziegler D, Pirtea P, Andersen CY, Ayoubi JM. Role of gonadotropin-releasing hormone agonists, human chorionic gonadotropin (hCG), progesterone, and estrogen in luteal phase support after hCG triggering, and when in pregnancy hormonal support can be stopped. Fertil Steril. 2018 May;109(5):749-755. doi: 10.1016/j.fertnstert.2018.03.006.

    PubMed 29778367

  • Thomsen LH, Kesmodel US, Andersen CY, Humaidan P. Daytime Variation in Serum Progesterone During the Mid-Luteal Phase in Women Undergoing In Vitro Fertilization Treatment. Front Endocrinol (Lausanne). 2018 Mar 19;9:92. doi: 10.3389/fendo.2018.00092. eCollection 2018.

    PubMed 29615975

  • Shoham G, Leong M, Weissman A. A 10-year follow-up on the practice of luteal phase support using worldwide web-based surveys. Reprod Biol Endocrinol. 2021 Jan 26;19(1):15. doi: 10.1186/s12958-021-00696-2.

    PubMed 33499875

  • Wang NF, Bungum L, Skouby SO. What is the optimal luteal support in assisted reproductive technology? Horm Mol Biol Clin Investig. 2021 Feb 22;43(2):225-233. doi: 10.1515/hmbci-2020-0081.

    PubMed 33609426

  • Balasch J, Martinez F, Jove I, Cabre L, Coroleu B, Barri PN, Vanrell JA. Inadvertent gonadotrophin-releasing hormone agonist (GnRHa) administration in the luteal phase may improve fecundity in in-vitro fertilization patients. Hum Reprod. 1993 Jul;8(7):1148-51. doi: 10.1093/oxfordjournals.humrep.a138210.

    PubMed 8408503

  • Tesarik J, Hazout A, Mendoza C. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation. Hum Reprod. 2004 May;19(5):1176-80. doi: 10.1093/humrep/deh235. Epub 2004 Apr 7.

    PubMed 15070873

  • Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.

    PubMed 16926261

  • Fusi FM, Arnoldi M, Bosisio C, Lombardo G, Ferrario M, Zanga L, Galimberti A, Capitanio E. Ovulation induction and luteal support with GnRH agonist in patients at high risk for hyperstimulation syndrome. Gynecol Endocrinol. 2015;31(9):693-7. doi: 10.3109/09513590.2015.1025379. Epub 2015 Aug 31.

    PubMed 26527503

  • Ma X, Du W, Hu J, Yang Y, Zhang X. Effect of Gonadotrophin-Releasing Hormone Agonist Addition for Luteal Support on Pregnancy Outcome in vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: A Meta-Analysis Based on Randomized Controlled Trials. Gynecol Obstet Invest. 2020;85(1):13-25. doi: 10.1159/000501204. Epub 2019 Aug 16.

    PubMed 31422404

  • Aboulghar MA, Marie H, Amin YM, Aboulghar MM, Nasr A, Serour GI, Mansour RT. GnRH agonist plus vaginal progesterone for luteal phase support in ICSI cycles: a randomized study. Reprod Biomed Online. 2015 Jan;30(1):52-6. doi: 10.1016/j.rbmo.2014.09.017. Epub 2014 Oct 13.

    PubMed 25456166

  • Isikoglu M, Ozgur K, Oehninger S. Extension of GnRH agonist through the luteal phase to improve the outcome of intracytoplasmic sperm injection. J Reprod Med. 2007 Jul;52(7):639-44.

    PubMed 17847764

  • Martins WP, Ferriani RA, Navarro PA, Nastri CO. GnRH agonist during luteal phase in women undergoing assisted reproductive techniques: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2016 Feb;47(2):144-51. doi: 10.1002/uog.14874. Epub 2015 Dec 30.

    PubMed 25854891

  • Qu D, Li Y. Multiple-dose versus single-dose gonadotropin-releasing hormone agonist after first in vitro fertilization failure associated with luteal phase deficiency: A randomized controlled trial. J Int Med Res. 2020 Jun;48(6):300060520926026. doi: 10.1177/0300060520926026.

    PubMed 32495663

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing gonadotropin releasing hormone-agonist and Progesterone in people with Female Infertility, run by Alexandria 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 4 inclusion and 5 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 29 Jan 2025. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Clinical pregnancy rate (time frame: 2 weeks after positive pregnancy test). 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 NCT05286554, which also lists 13 linked publications.

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 29 Jan 2025.

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