Infertility (IVF Patients)Phase 3GRACENCT07216742
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
A Phase 3 study testing hMG subcutaneous injection in people with Infertility (IVF Patients), run by Granata Bio Corporation at 16 sites in United States.
Trial summary
The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility (IVF Patients)
- What is being tested?
- hMG subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 659 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Nov 2025to Nov 2028
- Phase
- Phase 3
- 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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal women aged 18-42 years old at the time of consent.
- BMI ≥18 and <38 kg/m² at the time of consent.
- Menstrual cycles between 21-35 days.
- Normal mammogram or breast ultrasound if patient is >40 or if participant is younger as indicated by physician recommendation, within 2 years of screening.
- Anti-Müllerian hormone (AMH) >1.2 ng/ml within 6 months of screening.
- If donor sperm is used, donor must be 18-40 years of age at the time of collection and compliant with 21 Code of Regulations (CFR) section 1271 Subpart C.
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- Transvaginal ultrasound (TVUS) documenting presence and adequate visualization of both ovaries without ovarian enlargement, normal adnexa, and both ovaries accessible for oocyte retrieval at screening or within 6 months of screening.
- Valid medical indication for in vitro fertilization (IVF) treatment and subsequent embryo transfer (i.e. history of infertility according to current American Society of Reproductive Medicine (ASRM) definition, single women or same-sex couples) with the intention to achieve pregnancy within 12 months of the first stimulation cycle.
- Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a normal uterine cavity (i.e. no müllerian duct anomaly, uterine fibroids, endometrial polyps, intrauterine adhesions, adenomyosis) at screening or within 1 year prior to screening.
- Cervical cancer screening completed per current American College of Obstetricians and Gynecologists (ACOG) guidelines. Participants with abnormal findings may be included if deemed not clinically significant and not a safety concern for mother or fetus, at the discretion of the PI
- Negative serum hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody tests at screening.
- Absence of hydrosalpinx confirmed by hysterosalpingogram (HSG), sonohysterogram, laparoscopy, or other appropriate imaging within the past 12 months.
- Willing to undergo up to two ovarian stimulation cycles prior to frozen embryo transfer.
- Willing to self-administer study medications.
- Willing to have trophectoderm biopsy of all blastocyst stage embryos.
- Willing to accept transfer of one euploid embryo.
- Willing to vitrify and warm embryo(s) with intention to have a Frozen Embryo Transfer (FET).
- Willing and able to comply with the protocol and schedule of events for the duration of the study as well as providing delivery data and neonatal health data.
Who cannot join
- Persistent (for >1 cycle), clinically relevant (per PI discretion) ovarian cystic lesion (≥20 mm), including ovarian endometrioma or dermoid cyst.
- Participants with hepatic impairment (liver function tests > 2x upper limit of normal). Participants with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2).
- Uncontrolled adrenal, thyroid dysfunction or uncontrolled diabetes (HbA1C >7% within 3 months from screening).
- Greater than one IVF cycle canceled due to inability to meet ovulation trigger criteria (i.e. at least 2-3 follicles reach ≥18 mm.).
- History of recurrent implantation failure (RIF), defined according to the Lugano Consensus as the absence of implantation after transfer of ≥4 good-quality embryos in ≥3 embryo transfer (ET) cycles in women under the age of 40, using autologous oocytes.
- Recurrent pregnancy loss (RPL) is defined by two or more miscarriages; that is clinical pregnancies with the same partner and documented by ultrasonography or histopathological examination.
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- Known history of anovulation.
- Antral Follicle Count (AFC) <5 at screening.
- One or more dominant follicles (≥11 mm) observed on TVUS prior to randomization on stimulation day 1 with evidence of functional activity defined as serum Estradiol level >100 pg/ml.
- Past or current history of an estrogen dependent malignancy
- Untreated atypical endometrial hyperplasia
- Any contraindication to the use of oral contraceptives
- History of OHSS.
- Morphological sperm evidence of globozoospermia or prior failed oocyte fertilization in previous IVF cycle.
- The use of donor sperm back up or rescue for fertilization of oocytes.
- Use of calcium ionophore or treatment of sperm with methyl xanthines.
- The need for surgically retrieved sperm (i.e. testicular sperm extraction [TESE], Percutaneous Epididymal Sperm Aspiration [PESA]).
- Use of any investigational drug throughout the study, or within 3 months before screening or 5 half-lives whichever is longer.
- Use of any concomitant medications that would interfere with the study drug and with the evaluation of the study (e.g., hormonal medications or other medications affecting reproductive function), as determined by the investigator, unless permitted by the protocol or meeting required washout criteria.
- Current use or dependence on psychotropic medications that are contraindicated during pregnancy or have known or suspected fetal risk, unless the Investigator determines that the potential benefit outweighs the risk.
- Required chronic use of non-steroidal anti-inflammatory drugs during cycle.
- Treatment with clomiphene citrate, metformin, cabergoline, gonadotropins, or GnRH analogs within 1 month prior to randomization.
- Pregnancy, lactation, or contraindication to gonadotropins.
- Known thrombophilia or history of blood clots unless fully evaluated and cleared by a hematologist and receiving appropriate prophylaxis.
- Known abnormal karyotype in the patient or her partner that is considered clinically significant, such as numerical or structural chromosomal abnormalities (e.g., translocations, inversions, aneuploidies) known to impair fertility, increase risk of miscarriage, or result in genetic disorders in offspring.
- Current tobacco or marijuana user.
- Current or past (last 12 months) abuse of alcohol or drugs.
- Current use of dietary supplements containing high dose of biotin (>300µg), if prior use washout period of 1 week prior to randomization.
- No use of bioidentical hormones during stimulation or up to three months prior to start of stimulation. If prior use: washout period of three months prior to being randomized.
- A history of chemotherapy or radiotherapy.
- Undiagnosed uterine bleeding.
- Tumors of the ovary, breast, adrenal gland, pituitary, or hypothalamus; malformation of sexual organs incompatible with pregnancy.
- Known active pelvic inflammatory disease.
- Current, untreated submucosal fibroids or Intramural fibroids ≥5 cm or otherwise clinically relevant pathology that could impair embryo implantation or pregnancy continuation.
- The presence of severe endometriosis (ASRM stage 3 or stage 4) confirmed by laparoscopy, Magnetic Resonance Imaging (MRI), or pelvic ultrasound.
- Concomitant participation in another study protocol.
- Couples identified as carriers of the same autosomal recessive genetic condition associated with serious health outcomes in offspring will be excluded from the trial.
- Planned use of a gestational carrier.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Reproductive Biology Associates (RBA)
Atlanta, Georgia, 30342
CARE Fertility
Bedford, Texas, 76022
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010
Reach Fertility
Charlotte, North Carolina, 28207
Fertility Centers of Illinois
Chicago, Illinois, 60610
HRC Fertility
Encino, California, 91436
Fertility Institute of Hawaii
Honolulu, Hawaii, 96814
IVF Florida Reproductive Associates
Margate, Florida, 33036
Reproductive Associates of Delaware CCRM
Newark, Delaware, 19713
Illume Fertility
Norwalk, Connecticut, 06851
Pinnacle Fertility - Oregon
Portland, Oregon, 97205
Carolina Conceptions
Raleigh, North Carolina, 27607
Shady Grove Fertility - Rockville
Rockville, Maryland, 20850
Boston IVF
Waltham, Massachusetts, 02451
Shady Grove Houston
Webster, Texas, 77598
Center for Reproductive Medicine
Winter Park, Florida, 32789
About this study
Official title: A Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of a Human Menopausal Gonadotropin in the Development of Multiple Follicles, Pregnancy, and Cumulative Live Birth as Part of an Assisted Reproductive Technology (ART) Cycle.
The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in women with a diagnosis of infertility.
- Conditions
- Infertility (IVF Patients)
- Being tested
- hMG subcutaneous injection, Placebo
- Keywords
- Controlled ovarian stimulation, Gonadotropins, frozen embryo transfer, cumulative live birth rate, hMG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hMG subcutaneous injectionDrug
daily subcutaneous injection
PlaceboDrug
daily subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| hMG | Experimental | Human Menopausal Gonadotropin, daily subcutaneous injection Receives: Drug: hMG subcutaneous injection |
| Placebo | Placebo comparator | Placebo, daily subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative live birth rate
cumulative live birth rate following vitrified-thawed, single-euploid blastocyst transfer(s)
Measured: 12 months
Secondary outcomes (26)
Positive pregnancy (serum β-human chorionic gonadotropin [hCG])
Measured: 10 +/-2 days after Embryo transfer
Clinical pregnancy (intrauterine gestational sac with fetal heartbeat)
Measured: 5 weeks ± 6 days post-embryo transfer
Ongoing pregnancy (intrauterine pregnancy with fetal heartbeat)
Measured: 10 weeks ± 6 days post-embryo transfer (ET)
Live birth rate
Measured: 9 months after ET
Number of oocytes retrieved per stimulation cycle
Measured: 12-22 days after controlled ovarian stimulation start
Number of metaphase II (MII) oocytes retrieved
Measured: 12-22 days after controlled ovarian stimulation start
Fertilization rate (proportion of MII oocytes with normal fertilization)
Measured: 12-22 days after Controlled Ovarian stimulation start
Number of Day 5 blastocysts from oocyte retrievals from Period 1 and Period 2
Measured: 12-22 days after controlled ovarian stimulation start
Total gonadotropin dose required per stimulation cycle
Measured: 12-20 days after start Controlled ovarian stimulation
Serum estradiol concentration on the day of ovulation trigger
Measured: 12-20 days after controlled ovarian stimulation start
Serum progesterone (P4) on Day 5 of stimulation
Measured: 5 days after start controlled ovarian stimulation
Serum Follicular Stimulation Hormone (FSH) level on stimulation day 1, pre-dose
Measured: 1 day of stimulation
Serum Luteinizing hormone (LH) level on stimulation day 1, pre-dose
Measured: 1 day of stimulation
Serum human Chorionic Gonadotropin (hCG) level on stimulation day 1, pre-dose
Measured: 1 day of stimulation
FSH level on stimulation day 1, 1-4 hours post dose
Measured: 1 day of stimulation
LH level on stimulation day 1, 1-4 hours post dose
Measured: 1 day of stimulation
hCG level on stimulation day 1, 1-4 hours post dose
Measured: 1 day of stimulation
FSH level on stimulation day 5
Measured: After 5 day of stimulation
LH level on stimulation day 5
Measured: After 5 day of stimulation
hCG level on stimulation day 5
Measured: After 5 day of stimulation
FSH level on last stimulation day
Measured: 12-20 days after controlled ovarian stimulation start
LH level on last stimulation day
Measured: 12-20 days after controlled ovarian stimulation start
hCG level on last stimulation day
Measured: 12-20 days after controlled ovarian stimulation start
FSH level on oocytes retrieval day
Measured: 12-22 days after controlled ovarian stimulation start
LH level on oocytes retrieval day
Measured: 12-22 days after controlled ovarian stimulation start
hCG level on oocytes retrieval day
Measured: 12-22 days after controlled ovarian stimulation start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Nov 2025
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 659 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Granata Bio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216742
- Sponsor's protocol ID
- GBHMG-301
- Acronym
- GRACE
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of a Human Menopausal Gonadotropin in the Development of Multiple Follicles, Pregnancy, and Cumulative Live Birth as Part of an Assisted Reproductive Technology (ART) Cycle.
- ClinicalTrials.gov ID
- NCT07216742
- Acronym / sponsor ID
- GRACE / GBHMG-301
- Conditions
- Infertility (IVF Patients)
- Keywords
- Controlled ovarian stimulation, Gonadotropins, frozen embryo transfer, cumulative live birth rate, hMG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 659 participants (estimated)
- Lead sponsor
- Granata Bio CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this multicenter, randomized, placebo-controlled, double-blind clinical trial is toto evaluate the efficacy and safety of a human menopausal gonadotropin (hMG) in the development of multiple follicles, pregnancy, and cumulative live birth as part of an Assisted Reproductive Technology (ART) cycle in in women with a diagnosis of infertility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hMG | Experimental | Drug: hMG subcutaneous injectionHuman Menopausal Gonadotropin, daily subcutaneous injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, daily subcutaneous injection |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Pre-menopausal women aged 18-42 years old at the time of consent.
- BMI ≥18 and <38 kg/m² at the time of consent.
- Menstrual cycles between 21-35 days.
- Normal mammogram or breast ultrasound if patient is >40 or if participant is younger as indicated by physician recommendation, within 2 years of screening.
- Anti-Müllerian hormone (AMH) >1.2 ng/ml within 6 months of screening.
Key exclusion criteria (38 listed)
- Persistent (for >1 cycle), clinically relevant (per PI discretion) ovarian cystic lesion (≥20 mm), including ovarian endometrioma or dermoid cyst.
- Participants with hepatic impairment (liver function tests > 2x upper limit of normal). Participants with renal impairment (estimated creatinine clearance <60 mL/min/1.73 m2).
- Uncontrolled adrenal, thyroid dysfunction or uncontrolled diabetes (HbA1C >7% within 3 months from screening).
- Greater than one IVF cycle canceled due to inability to meet ovulation trigger criteria (i.e. at least 2-3 follicles reach ≥18 mm.).
- History of recurrent implantation failure (RIF), defined according to the Lugano Consensus as the absence of implantation after transfer of ≥4 good-quality embryos in ≥3 embryo transfer (ET) cycles in women under the age of 40, using autologous oocytes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hMG subcutaneous injectiondaily subcutaneous injection | Drug | hMG |
| Placebodaily subcutaneous injection | Drug | Placebo |
Primary outcome
cumulative live birth rate
Time frame: 12 months
cumulative live birth rate following vitrified-thawed, single-euploid blastocyst transfer(s)
26 secondary outcomes
Positive pregnancy (serum β-human chorionic gonadotropin [hCG])
Time frame: 10 +/-2 days after Embryo transfer
Clinical pregnancy (intrauterine gestational sac with fetal heartbeat)
Time frame: 5 weeks ± 6 days post-embryo transfer
Ongoing pregnancy (intrauterine pregnancy with fetal heartbeat)
Time frame: 10 weeks ± 6 days post-embryo transfer (ET)
Live birth rate
Time frame: 9 months after ET
Number of oocytes retrieved per stimulation cycle
Time frame: 12-22 days after controlled ovarian stimulation start
Number of metaphase II (MII) oocytes retrieved
Time frame: 12-22 days after controlled ovarian stimulation start
Fertilization rate (proportion of MII oocytes with normal fertilization)
Time frame: 12-22 days after Controlled Ovarian stimulation start
Number of Day 5 blastocysts from oocyte retrievals from Period 1 and Period 2
Time frame: 12-22 days after controlled ovarian stimulation start
Total gonadotropin dose required per stimulation cycle
Time frame: 12-20 days after start Controlled ovarian stimulation
Serum estradiol concentration on the day of ovulation trigger
Time frame: 12-20 days after controlled ovarian stimulation start
Serum progesterone (P4) on Day 5 of stimulation
Time frame: 5 days after start controlled ovarian stimulation
Serum Follicular Stimulation Hormone (FSH) level on stimulation day 1, pre-dose
Time frame: 1 day of stimulation
Serum Luteinizing hormone (LH) level on stimulation day 1, pre-dose
Time frame: 1 day of stimulation
Serum human Chorionic Gonadotropin (hCG) level on stimulation day 1, pre-dose
Time frame: 1 day of stimulation
FSH level on stimulation day 1, 1-4 hours post dose
Time frame: 1 day of stimulation
LH level on stimulation day 1, 1-4 hours post dose
Time frame: 1 day of stimulation
hCG level on stimulation day 1, 1-4 hours post dose
Time frame: 1 day of stimulation
FSH level on stimulation day 5
Time frame: After 5 day of stimulation
LH level on stimulation day 5
Time frame: After 5 day of stimulation
hCG level on stimulation day 5
Time frame: After 5 day of stimulation
FSH level on last stimulation day
Time frame: 12-20 days after controlled ovarian stimulation start
LH level on last stimulation day
Time frame: 12-20 days after controlled ovarian stimulation start
hCG level on last stimulation day
Time frame: 12-20 days after controlled ovarian stimulation start
FSH level on oocytes retrieval day
Time frame: 12-22 days after controlled ovarian stimulation start
LH level on oocytes retrieval day
Time frame: 12-22 days after controlled ovarian stimulation start
hCG level on oocytes retrieval day
Time frame: 12-22 days after controlled ovarian stimulation start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hMG subcutaneous injection in people with Infertility (IVF Patients), run by Granata Bio Corporation at 16 sites in United States.
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 18 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
cumulative live birth rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.