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Infertility (IVF Patients)NCT07771283

Purpose to Evaluate the Effectiveness of the Superovulation Stimulation Protocol Using Human Chorionic Gonadotropin (hCG) by Demonstrating Its Equivalence to Standard Controlled Ovarian Stimulation Protocols in Terms of Oocytes Retrieved, Blastulation While Maintaining an Economic Advantage

A study testing Human Chorionic Gonadotropin (hCG), GnRH antagonist and Dual trigger (human chorionic gonadotropin plus GnRH-agonist) in people with Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro at 3 sites in 2 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study evaluates a more affordable medication protocol for ovarian stimulation during in vitro fertilization (IVF). Standard IVF protocols use medications called gonadotropins to stimulate the ovaries to produce multiple eggs, but these medications can be very expensive and create a barrier to treatment. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
What is being tested?
Human Chorionic Gonadotropin (hCG), GnRH antagonist and Dual trigger (human chorionic gonadotropin plus GnRH-agonist)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
3 sitesin 2 countries
Study dates
17 Aug 2026to 1 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women of reproductive age between 18 and 40 years.
  • Clinical indications for the induction of superovulation (undergoing ART/IVF programs).
  • Patients with all variants of ovarian reserve.
  • Body Mass Index (BMI) up to 35 kg/m².
  • Provision of informed consent to participate in the research study.

Who cannot join

  • Presence of ovarian endometriomas.
  • History of severe Ovarian Hyperstimulation Syndrome (OHSS) in previous cycles.
  • Presence of severe endocrine disorders.
  • History or presence of oncological diseases.
  • Any medical contraindications to hormonal stimulation.
  • Severe male factor infertility (specifically cryptozoospermia)

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

3 sites in 2 countries

Ukraine2 sites
  • LTD "Yuzko" Yuzko Medical Center

    Chernivtsi

  • LTD "EKODNIPRO" Medical Centre "Medical Plaza"

    Dnipro

Other trials in Ukraine

Uganda1 site
  • Sali international school of fertility medicine

    Kampala

Other trials in Uganda

About this study

Official title: Prospective Randomized Single-Blind Study of the Effectiveness of the Superovulation Stimulation Protocol Using hCG Compared to Standard Protocols With Different Gonadotropin Doses in In Vitro Fertilization Programs

This study evaluates a more affordable medication protocol for ovarian stimulation during in vitro fertilization (IVF). Standard IVF protocols use medications called gonadotropins to stimulate the ovaries to produce multiple eggs, but these medications can be very expensive and create a barrier to treatment. This clinical trial tests whether substituting a significant portion of these standard medications with human chorionic gonadotropin (hCG) is just as effective. Researchers will compare the number and quality of eggs and embryos produced by women using the experimental hCG protocol versus those using the standard gonadotropin protocol. The main goal is to determine if the hCG method can provide similar clinical outcomes and safety profiles while significantly reducing the overall financial cost of IVF treatment.

Read the detailed description

Ovarian stimulation is a critical phase in assisted reproductive technologies (ART), but the high cost of recombinant gonadotropins remains a significant barrier to the accessibility of care for many patients. Human chorionic gonadotropin (hCG), due to its structural similarity to luteinizing hormone (LH), binds to LH/hCG receptors and can effectively support steroidogenesis and folliculogenesis when administered in sub-trigger doses. This prospective, randomized, single-blind trial is designed as a non-inferiority study to demonstrate that an hCG-based stimulation protocol is equivalent to standard controlled ovarian stimulation. While standard protocols rely on the continuous administration of follicle-stimulating hormone (FSH) or FSH/LH, the experimental protocol introduces 200 IU of hCG (without FSH) to replace standard gonadotropins once the main cohort of follicles reaches 11 to 12 millimeters in size. Both treatment arms will utilize a fixed gonadotropin-releasing hormone (GnRH) antagonist protocol starting on day 6 of stimulation, followed by a dual trigger for final oocyte maturation. To minimize bias and ensure objective results, the embryologists evaluating oocyte morphology, fertilization rates, and blastocyst development will be blinded to the treatment arm assignments. If moderate or severe ovarian hyperstimulation syndrome (OHSS) is suspected in the experimental group, the protocol incorporates safety measures, including switching to a GnRH agonist trigger and utilizing a "freeze-all" strategy. By thoroughly comparing these methods through both intention-to-treat (ITT) and per-protocol (PP) analyses, researchers aim to validate an individualized treatment approach. Proving the non-inferiority of this alternative protocol could potentially reduce the medication cost of an IVF cycle by 30 to 60 percent, providing clinicians with a flexible, cost-effective tool without compromising clinical efficacy or patient safety.

Being tested
Human Chorionic Gonadotropin (hCG), GnRH antagonist, Dual trigger (human chorionic gonadotropin plus GnRH-agonist), Gonadotropins (FSH or FSH/LH)
Keywords
Human Chorionic Gonadotropin (hCG), Infertility, Female Infertility, Gonadotropins, Assisted Reproductive Technology (ART), Controlled Ovarian Stimulation (COS), Ovarian Stimulation
Medical subject headings
Infertility, Infertility, Female

What participants receive

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

  • Human Chorionic Gonadotropin (hCG)Drug

    Administered in sub-trigger doses of 200 IU (without FSH) as a substitute for LH activity and to support folliculogenesis

  • GnRH antagonistDrug

    Administered starting on the 6th day of stimulation as part of a fixed antagonist protocol

  • Dual trigger (human chorionic gonadotropin plus GnRH-agonist)Drug

    Also called GnRH-agonist in case high risk of OHSS

    Administered to induce final oocyte maturation before retrieval

  • Gonadotropins (FSH or FSH/LH)Drug

    Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day.

  • Gonadotropins (FSH or FSH/LH)Drug

    Standard follicle-stimulating hormone (FSH) or FSH/LH preparations administered continuously at doses ranging from 100 to 225 IU/day before main cohort of follicles reach size 11-12mm

Study groups in NCT07771283
Study groupRoleWhat they receive
hCG ProtocolExperimentalatients in this group undergo ovarian stimulation where human chorionic gonadotropin (hCG) replaces standard gonadotropins (or a significant portion of them) once the main cohort of follicles reaches 11-12 mm in size. This arm utilizes a fixed gonadotropin-releasing hormone (GnRH) antagonist protocol starting on day 6 of stimulation and a dual trigger for final maturation.
Receives: Drug: Human Chorionic Gonadotropin (hCG); Drug: GnRH antagonist; Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist); Drug: Gonadotropins (FSH or FSH/LH)
Standard ProtocolActive comparatorPatients in this group undergo standard controlled ovarian stimulation using continuous administration of gonadotropins. This arm also utilizes a fixed gonadotropin-releasing hormone (GnRH) antagonist protocol starting on day 6 of stimulation and a dual trigger for final maturation
Receives: Drug: GnRH antagonist; Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist); Drug: Gonadotropins (FSH or FSH/LH)

What is being measured

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

  1. Number of oocytes retrieved (oocyte yield)

    The total count of oocytes retrieved following the controlled ovarian stimulation protocol

    Measured: Day of oocyte retrieval (typically 34-36 hours after trigger administration)

  2. Proportion of Mature Oocytes (MII Rate)

    Description: The percentage of retrieved oocytes that have reached the Metaphase II (MII) stage, evaluated according to the standardized ESHRE/ALPHA (Istanbul Consensus, 2025 update) criteria

    Measured: Day of oocyte retrieval

  3. Fertilization Rate

    The percentage of mature oocytes (MII) that are successfully fertilized.

    Measured: Day 1 following oocyte retrieval

  4. Embryo Quality

    The percentage of good quality cleavage-stage embryos and good quality blastocysts, assessed according to the standardized ESHRE/ALPHA (Istanbul Consensus, 2025 update) criteria.

    Measured: Day 3 and Day 5 following oocyte retrieval

  5. Total Dose of Gonadotropins/hCG

    The total cumulative dose in International Units (IU) of gonadotropins or hCG administered throughout the entire stimulation cycle

    Measured: From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)

Secondary outcomes (6)
  1. Clinical Pregnancy Rate

    The percentage of patients who achieve a clinical pregnancy following embryo transfer

    Measured: Approximately 4 to 6 weeks following embryo transfer

  2. Live Birth Rate

    The percentage of patients who achieve a live birth

    Measured: Approximately 9 to 10 months following embryo transfer

  3. Incidence of Ovarian Hyperstimulation Syndrome (OHSS)

    The frequency of moderate and severe OHSS cases, classified according to RCOG/ESHRE criteria

    Measured: From the day of trigger administration through the luteal phase/early pregnancy

  4. Average Duration of Stimulation

    The total number of days the stimulation medications were administered.

    Measured: From Day 1 of stimulation up to the day of trigger administration (approximately 10-14 days)

  5. Endometrial Thickness

    The thickness of the endometrium measured in millimeters (mm) via ultrasound

    Measured: On the day of trigger administration

  6. Cost of Stimulation Protocol per Cycle

    An economic evaluation calculating the total cost of all medications consumed during the stimulation cycle, initially recorded in UAH and converted to USD.

    Measured: At the completion of the stimulation protocol (day of trigger)

Timeline

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

  1. First posted18 Aug 2026
  2. Study start17 Aug 2026
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 May 2028 (estimated)

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
Model description
This is a prospective, randomized, parallel-group, non-inferiority trial. Participants are allocated to one of two treatment groups (Group A or Group B) using block randomization (block size of 6) stratified by the participating institution. Allocation concealment is ensured through the use of Sequentially Numbered Opaque Sealed Envelopes (SNOSE). Due to the distinct differences in medication administration regimens between the two groups, the study is open-label for the patients and the treating physicians. However, to minimize bias, the study employs a single-blind outcome assessment design. The embryologists responsible for evaluating oocyte and embryo quality, as well as the personnel assessing clinical pregnancy and live birth rates, will be completely blinded to the participants' assigned treatment groups.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07771283
Sponsor's protocol ID
2
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in the final published article will be shared. This includes data collected for the primary and secondary endpoints, after appropriate anonymization to ensure strict compliance with GDPR and Ukrainian data protection laws.

Publications

  • Huong NTL, Thuy TT, Anh PTT, Long HB, Thang LD, Ngoc VT, Do LQ, Duy NXA, Hanh BT, Loi DV, Hoang L. Effects of 100 IU versus 150 IU hCG supplementation on oocyte and embryo quality in patients aged >/= 35 years: a propensity score-matched analysis. Int J Med Sci. 2025 Jan 27;22(4):982-989. doi: 10.7150/ijms.106965. eCollection 2025.

    PubMed 39991766
  • Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.

    PubMed 19617207
  • Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.

    PubMed 16084880
  • Lin H, Huang X, Zhao Y, Wang Y, Wang S, Hong F, Pan M, Liu L. Low-dose human chorionic gonadotropin supplementation initiated at the onset of ovarian stimulation can improve oocyte quality without impairing endometrial receptivity: Case series. Medicine (Baltimore). 2022 Dec 2;101(48):e32175. doi: 10.1097/MD.0000000000032175.

    PubMed 36482630

Questions about this trial

What is this clinical trial studying?

A study testing Human Chorionic Gonadotropin (hCG), GnRH antagonist and Dual trigger (human chorionic gonadotropin plus GnRH-agonist) in people with Infertility (IVF Patients) and Infertility Assisted Reproductive Technology, run by LTD "EKODNIPRO", Medical centre Medical Plaza Dnipro at 3 sites in 2 countries.

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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ukraine, Uganda. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of oocytes retrieved (oocyte yield) (time frame: Day of oocyte retrieval (typically 34-36 hours after trigger administration)). The study lists 5 primary outcomes in all. 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 NCT07771283, which also lists 4 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 27 Aug 2026.

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Clinical Trial NCT07771283 | AzTrials