InfertilityPhase 3NCT07340827
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
A Phase 3 study testing Follitropin alfa/lutropin alfa (MBJ-0011), hMG and Cetrorelix acetate in people with Infertility, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 21 sites in Japan.
Trial summary
The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Follitropin alfa/lutropin alfa (MBJ-0011), hMG and Cetrorelix acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 21 sitesJapan
- Study dates
- 5 Feb 2026to 30 Sep 2027
- 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
- Participants who are premenopausal wishing to conceive
- Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
- Japanese Participants
- Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
- Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
- A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology
- Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening
- Other protocol defined criteria may apply
Who cannot join
- Participants with history of severe OHSS in any previous ovarian stimulation cycle
- Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
- Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
- Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
- Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
- other protocol defined exclusion criteria may apply
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
Japan21 sites, 21 recruiting
- Recruiting
Akita University Hospital - Dept of Obstetrics/Gynecology
Akita, Akita, 010-8543
teraday@doc.med.akita-u.ac.jp
Yukihiro Terada
- Recruiting
Juntendo University Hospital - Dept of Obstetrics/ Gynecology
Bunkyō City, Tokyo-To, 113-8431
kazuhironanami@gmail.com
Kazuhiro Kawamura
- Recruiting
University of Tokyo Hospital - Dept of Obstetrics
Bunkyō City, Tokyo-To, 113-8655
haradamtky@gmail.com
Miyuki Harada
- Recruiting
Kameda IVF Clinic Makuhari - Dept of Obstetrics/Gynecology
Chiba, Chiba, 261-8501
kawaikiyotaka@wfc-mom.jp
Kiyotaka Kawai
- Recruiting
Sugiyama Clinic Marunouchi - Dept of Obstetrics/ Gynecology
Chiyoda-ku, Tokyo-To, 100-0005
kuroda@sugiyama.or.jp
Keiji Kuroda
- Recruiting
Sankeikai IVF Osaka Clinic - Dept of Obstetrics/Gynecology
Higashiosaka-shi, Osaka, 577-0012
chiken2026@yahoo.co.jp
Aisaku Fukuda
- Recruiting
Hanabusa Women's Clinic Hanabusa Women's Central Fertility Clinic - Dept of Obstetrics/Gynecology
Kobe, Hyōgo, 650-0021
kokeguchi@hanabusaclinic.com
Shoji Kokeguchi
- Recruiting
Ladies Clinic Cosmos - Dept of Infertility Treatment
Kochi, Kochi, 780-0072
ch.kuwahara@lccosmos.jp
Akira Kuwahara
- Recruiting
YOKOTA Maternity Hospital - Dept of Reproductive Medical Gynecology
Maebashi, Gunma, 371-0031
yoshimasa0709yokota@gmail.com
Yoshimasa Yokota
- Recruiting
Nagano Municipal Hospital - Dept of Gynecology
Nagano, Nagano, 381-8551
hiroko_sakon@hospital.nagano.nagano.jp
Hiroko Sakon
- Recruiting
JA-Nagano Shinonoi General Hospital - Dept of Obstetrics/Gynecology
Nagano, Nagano, 388-8004
ryohei-n@yg8.so-net.ne.jp
Ryohei Nishimura
- Recruiting
Haruki Ladies Clinic - Dept of Gynecology
Osaka, Osaka, 542-0081
haruki@haruki-cl.com
Atsushi Haruki
- Recruiting
Toho University Omori Medical Center - Dept of Obstetrics/Gynecology
Ōta-ku, Tokyo-To, 143-8541
yukikonk@med.toho-u.ac.jp
Yukiko Katagiri
- Recruiting
Sophia Ladies Clinic - Dept of Obstetrics/Gynecology
Sagamihara-shi, Kanagawa, 252-0233
hase009@sophia-lc.jp
Tomoya Hasegawa
- Recruiting
KASHIWAZAKI OB/GYN CLINIC - Dept of Obstetrics/Gynecology
Saitama-shi, Saitama, 330-0855
yujiy1012@yahoo.co.jp
Yuji Kashiwazaki
- Recruiting
Omiya Ladies Clinic - Dept of Gynecology
Saitama-shi, Saitama, 330-8669
s-idei@omiya-lc.com
Sadayoshi Idei
- Recruiting
Kamiya Ladies Clinic - Dept of Gynecology
Sapporo, Hokkaido, 060-0003
nanakoiwami@gmail.com
Nanako Iwami
- Recruiting
Sora no Mori Clinic - Dept of Obstetrics/Gynecology
Shimajiri-gun, Okinawa, 901-0406
atsushi_fukui@azukikai.or.jp
Atsushi Fukui
- Recruiting
Dokkyo Medical University Hospital - Dept of Reproduction Center
Shimotsuga-gun, Tochigi, 321-0293
t-suzuki796@dokkyomed.ac.jp
Tatsuya Suzuki
- Recruiting
Sugiyama Clinic Shinjuku - Dept of Reproductive Medical
Shinjuku-ku, Tokyo-To, 160-0023
awaodori84057@gmail.com
Koij Nakagawa
- Recruiting
Tokushima University Hospital - Dept of Obstetrics/Gynecology
Tokushima, Tokushima, 770-8503
iwasa.takeshi@tokushima-u.ac.jp
Takeshi Iwasa
About this study
Official title: A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART
The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).
The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.
- Conditions
- Infertility
- Being tested
- Follitropin alfa/lutropin alfa (MBJ-0011), hMG, Cetrorelix acetate, Coriogonadotropin alfa, Progesterone gel
- Keywords
- Gonadotropins, infertility, prefilled pen
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin alfa/lutropin alfa (MBJ-0011)Combination product
Also called MBJ-0011, r-hFSH/r-hLH
Follitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days.
hMGDrug
Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
Cetrorelix acetateDrug
Also called GnRH, antagonist
Participants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG.
Coriogonadotropin alfaDrug
Also called r-hCG
Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
Progesterone gelDrug
Participants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Follitropin alfa/lutropin alfa | Experimental | Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio. Receives: Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011); Drug: Cetrorelix acetate; Drug: Coriogonadotropin alfa; Drug: Progesterone gel |
| Arm 2: Human Menopausal Gonadotropin (hMG) | Active comparator | Not described Receives: Drug: hMG; Drug: Cetrorelix acetate; Drug: Coriogonadotropin alfa; Drug: Progesterone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of oocytes retrieved
Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
Measured: At approximately 36 to 38 hours after r-hCG administration (Day 4)
Secondary outcomes (14)
Total dose of gonadotropin (IU) used
Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH.
Measured: At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)
Number of Days of Gonadotropin Treatment
Total number of days of ovarian stimulation will be reported.
Measured: At Visit 3 after ovarian stimulation from Day 5-18
Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter
Measured: During Ovarian stimulation (Day 5 to Day 18)
Serum Estradiol (E2) levels
Measured: At Visit 3 after ovarian stimulation from Day 5-18
Proportion of 2 Pronuclei Embryos/Fertilized Oocytes
The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported.
Measured: At 18 (Plus or minus two hours) hours after insemination
Number of blastocysts frozen
After the transfer of 1 fresh blastocysts - spare ones will be frozen.
Measured: 5 days after insemination
Number of Participants With Clinical Pregnancy
A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or with or without heartbeat (fetal sac).
Measured: 35-42 days after Visit 5 (Blastocyst transfer)
Number of Participants With Ongoing Pregnancy
Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat.
Measured: up to 80 days after blastocyst transfer (pregnancy week 11 to 12)
Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events
Measured: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
Measured: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome
Measured: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome
Measured: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs
Measured: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants Experiencing Local Reactions
Pain redness, swelling, bruising, and itching around the injection site will be assessed.
Measured: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start5 Feb 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340827
- Sponsor's protocol ID
- MS132705_0007
- Other IDs
- jRCT2031250671
- Status last verified
- Oct 2026
- First submitted
- 6 Jan 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD supporting publicly available results will be evaluated for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-group Treatment, 2-arm Study to Compare the Efficacy and Safety of Follitropin Alfa and Lutropin Alfa Fixed Dose Combination Versus hMG for Inducing Follicular Development in Japanese Participants With LH and FSH Deficiency Undergoing ART
- ClinicalTrials.gov ID
- NCT07340827
- Acronym / sponsor ID
- MS132705_0007
- Conditions
- Infertility
- Keywords
- Gonadotropins, infertility, prefilled pen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 14 Jan 2026 (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 purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).
The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Follitropin alfa/lutropin alfa | Experimental | Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011), Drug: Cetrorelix acetate, Drug: Coriogonadotropin alfa, Drug: Progesterone gelParticipants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio. |
| Arm 2: Human Menopausal Gonadotropin (hMG) | Active comparator | Drug: hMG, Drug: Cetrorelix acetate, Drug: Coriogonadotropin alfa, Drug: Progesterone gel |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participants who are premenopausal wishing to conceive
- Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
- Japanese Participants
- Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
- Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
Key exclusion criteria (6 listed)
- Participants with history of severe OHSS in any previous ovarian stimulation cycle
- Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
- Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
- Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
- Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
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 |
|---|---|---|
| Follitropin alfa/lutropin alfa (MBJ-0011)Also: MBJ-0011, r-hFSH/r-hLHFollitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days. | Combination product | Arm 1: Follitropin alfa/lutropin alfa |
| hMGParticipants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation. | Drug | Arm 2: Human Menopausal Gonadotropin (hMG) |
| Cetrorelix acetateAlso: GnRH, antagonistParticipants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG. | Drug | Arm 1: Follitropin alfa/lutropin alfa, Arm 2: Human Menopausal Gonadotropin (hMG) |
| Coriogonadotropin alfaAlso: r-hCGParticipants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation. | Drug | Arm 1: Follitropin alfa/lutropin alfa, Arm 2: Human Menopausal Gonadotropin (hMG) |
| Progesterone gelParticipants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support. | Drug | Arm 1: Follitropin alfa/lutropin alfa, Arm 2: Human Menopausal Gonadotropin (hMG) |
Primary outcome
Total number of oocytes retrieved
Time frame: At approximately 36 to 38 hours after r-hCG administration (Day 4)
Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
14 secondary outcomes
Total dose of gonadotropin (IU) used
Time frame: At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)
Number of Days of Gonadotropin Treatment
Time frame: At Visit 3 after ovarian stimulation from Day 5-18
Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter
Time frame: During Ovarian stimulation (Day 5 to Day 18)
Serum Estradiol (E2) levels
Time frame: At Visit 3 after ovarian stimulation from Day 5-18
Proportion of 2 Pronuclei Embryos/Fertilized Oocytes
Time frame: At 18 (Plus or minus two hours) hours after insemination
Number of blastocysts frozen
Time frame: 5 days after insemination
Number of Participants With Clinical Pregnancy
Time frame: 35-42 days after Visit 5 (Blastocyst transfer)
Number of Participants With Ongoing Pregnancy
Time frame: up to 80 days after blastocyst transfer (pregnancy week 11 to 12)
Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants Experiencing Local Reactions
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
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 29 Oct 2026.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD supporting publicly available results will be evaluated for sharing.
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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.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
21 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 Follitropin alfa/lutropin alfa (MBJ-0011), hMG and Cetrorelix acetate in people with Infertility, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 21 sites in Japan.
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 8 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: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. 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 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?
Contact Communication Center (+49 6151 72 5200, service@emdgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of oocytes retrieved (time frame: At approximately 36 to 38 hours after r-hCG administration (Day 4)). 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 29 Oct 2026.