Infertility, FemaleELH-IVFNCT07128394
Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment
A study testing Recombinant Luteinizing Hormone (rLH), Recombinant Follicle-Stimulating Hormone (rFSH) and Gonadotropin-Releasing Hormone Agonist (GnRH-a) in people with Infertility, Female and Luteinizing Hormone (LH), run by Nanjing University at 1 site in China.
Trial summary
This randomized controlled trial aims to evaluate whether supplementation with exogenous luteinizing hormone (LH) can improve embryo quality in patients undergoing in vitro fertilization (IVF) with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol who have excessive suppression of LH. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Infertility, Female, Luteinizing Hormone (LH)
- What is being tested?
- Recombinant Luteinizing Hormone (rLH), Recombinant Follicle-Stimulating Hormone (rFSH) and Gonadotropin-Releasing Hormone Agonist (GnRH-a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 30 Nov 2026
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20 to 37 years (inclusive). Diagnosed with infertility and undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment using the long-acting GnRH agonist protocol.
- Serum luteinizing hormone (LH) level <0.5 U/L after pituitary downregulation. Normal uterine cavity as confirmed by hysteroscopy, sonohysterography, or hysterosalpingography within 6 months.
- Written informed consent provided prior to participation.
Who cannot join
- Polycystic ovary syndrome (PCOS). History of recurrent implantation failure (RIF). Presence of endometriosis or adenomyosis. History of ovarian surgery. Ovarian cysts ≥3 cm or with suspected malignancy. Poor ovarian reserve (antral follicle count <5, anti-Müllerian hormone <1.1 ng/mL, or baseline FSH >10 IU/L).
- Chromosomal abnormalities in either partner. Systemic diseases such as uncontrolled hypertension, diabetes, thyroid disorders, or autoimmune diseases.
- Contraindications to ovarian stimulation medications or pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital, Nanjing University Medical School
Nanjing, Jiangsu, 210008
Yue Jiang, PhD, +8613814122872, jiangyue85@163.com
Hui Zhang, PhD, +8618262637731, hellozhanghui@sina.cn
About this study
Official title: Exogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate whether supplementation with exogenous luteinizing hormone (LH) can improve embryo quality in patients undergoing in vitro fertilization (IVF) with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol who have excessive suppression of LH. Eligible participants will be randomly assigned to receive either exogenous LH supplementation or standard care. The primary outcome is embryo quality, and secondary outcomes include pregnancy rates and safety assessments. The study is conducted at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University.
Read the detailed description
Excessive suppression of luteinizing hormone (LH) during ovarian stimulation with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol has been associated with suboptimal follicular development, impaired oocyte maturation, and reduced embryo quality. LH plays a critical role in the final stages of folliculogenesis, steroidogenesis, and ovulation, and its deficiency during controlled ovarian hyperstimulation may adversely affect the developmental competence of oocytes.
This randomized controlled trial is designed to evaluate whether supplementation with exogenous LH can improve embryo quality in patients undergoing in vitro fertilization (IVF) with excessive LH suppression during a long GnRH-a protocol. Eligible participants are women meeting predefined hormonal suppression criteria prior to or during stimulation. Participants will be randomly assigned to receive either exogenous LH supplementation in addition to standard ovarian stimulation or standard care without LH supplementation.
The primary endpoint is the proportion of high-quality embryos obtained per cycle. Secondary endpoints include clinical pregnancy rate, implantation rate, live birth rate, and safety outcomes such as incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events.
The study aims to provide high-quality evidence to guide the optimal management of patients with profound LH suppression during controlled ovarian stimulation. Findings from this trial may contribute to refining stimulation protocols and improving reproductive outcomes in assisted reproductive technology (ART).
- Conditions
- Infertility, Female, Luteinizing Hormone (LH)
- Being tested
- Recombinant Luteinizing Hormone (rLH), Recombinant Follicle-Stimulating Hormone (rFSH), Gonadotropin-Releasing Hormone Agonist (GnRH-a)
- Keywords
- Luteinizing Hormone, Long GnRH Agonist Protocol, Excessive LH Suppression, Controlled Ovarian Stimulation, In Vitro Fertilization, Embryo Quality
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Luteinizing Hormone (rLH)Drug
Also called lutropin alfa, Luveris
Recombinant LH administered subcutaneously in combination with recombinant FSH (rFSH) at a ratio of 2:1 starting on stimulation day, continued throughout controlled ovarian hyperstimulation. Dosage adjusted according to follicular growth and serum hormone levels.
Recombinant Follicle-Stimulating Hormone (rFSH)Drug
Also called follitropin alfa, Gonal-F
Recombinant FSH administered subcutaneously for controlled ovarian hyperstimulation after pituitary downregulation with a long-acting GnRH agonist. Dosage adjusted based on follicular development and hormone monitoring.
Gonadotropin-Releasing Hormone Agonist (GnRH-a)Drug
Also called triptorelin, Diphereline
Long-acting GnRH agonist (3.75 mg) administered subcutaneously on menstrual cycle day 2-4 for pituitary downregulation before controlled ovarian hyperstimulation.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant LH Supplementation Group | Experimental | Participants receive controlled ovarian hyperstimulation (COH) using a long-acting GnRH agonist (triptorelin 3.75 mg) for pituitary downregulation, followed by recombinant FSH (rFSH) combined with recombinant LH (rLH) at a ratio of 2:1 starting on stimulation day. rLH administration continues throughout the stimulation phase, with gonadotropin doses adjusted based on follicular growth and hormone monitoring. Trigger is given when 2-3 leading follicles reach ≥18 mm, followed by oocyte retrieval, IVF/ICSI, and embryo quality assessment. Receives: Drug: Recombinant Luteinizing Hormone (rLH); Drug: Recombinant Follicle-Stimulating Hormone (rFSH); Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a) |
| Conventional rFSH-Only Group | Active comparator | Participants receive the same long-acting GnRH agonist downregulation and rFSH stimulation protocol as the experimental arm, but without rLH supplementation. Only rFSH is used during COH, with dose adjustments according to follicular development and hormone levels. Trigger, oocyte retrieval, IVF/ICSI, and embryo assessment follow the same procedures as in the experimental arm. Receives: Drug: Recombinant Follicle-Stimulating Hormone (rFSH); Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of cycles with no usable embryos
The number of IVF/ICSI cycles with no transferable embryos divided by the total number of oocyte retrieval cycles, evaluated based on embryo morphology and grading on Day 3 or Day 5-6 after fertilization.
Measured: 7 days after oocyte retrieval
Secondary outcomes (7)
Number of high-quality Day 3 embryos
Count of embryos meeting morphological criteria for high quality on Day 3 after fertilization, as determined by standard embryology scoring.
Measured: 7 days after oocyte retrieval
Total gonadotropin dose used
Cumulative dose (IU) of gonadotropins administered from stimulation start to trigger day.
Measured: At the end of ovarian stimulation (average 8-12 days)
Duration of gonadotropin stimulation
Number of days from gonadotropin initiation to trigger day.
Measured: At the end of ovarian stimulation (average 8-12 days)
Number of oocytes retrieved
Total number of oocytes collected during transvaginal ultrasound-guided oocyte retrieval.
Measured: At oocyte retrieval (36-38 hours after trigger)
Clinical pregnancy rate
Proportion of embryo transfer cycles resulting in at least one intrauterine gestational sac with fetal heartbeat, confirmed by transvaginal ultrasound.
Measured: 30 days after embryo transfer
Early miscarriage rate
Proportion of clinical pregnancies ending in miscarriage before 12 completed weeks of gestation.
Measured: Within 12 weeks of gestation
Live birth rate
Proportion of embryo transfer cycles resulting in the delivery of at least one live-born infant.
Measured: At delivery (up to 1 year after embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Feb 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving exogenous luteinizing hormone (LH) supplementation in addition to the standard long GnRH agonist protocol, or the control group receiving the standard long GnRH agonist protocol without LH supplementation. Both groups will undergo controlled ovarian stimulation and in vitro fertilization (IVF) according to the study protocol.
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
- Investigators
- 慧 Jiang, PhD, Principal investigator, Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128394
- Sponsor's protocol ID
- SZ-ELH-2025
- Other IDs
- BJHPA-2023-SZHYXZHQN-006
- Acronym
- ELH-IVF
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to concerns regarding patient privacy, confidentiality, and compliance with local regulations.
Publications
Yazici Yilmaz F, Gorkemli H, Colakoglu MC, Aktan M, Gezginc K. The evaluation of recombinant LH supplementation in patients with suboptimal response to recombinant FSH undergoing IVF treatment with GnRH agonist down-regulation. Gynecol Endocrinol. 2015 Feb;31(2):141-4. doi: 10.3109/09513590.2014.965675. Epub 2014 Sep 19.
PubMed 25237892Tesarik J, Mendoza C. Effects of exogenous LH administration during ovarian stimulation of pituitary down-regulated young oocyte donors on oocyte yield and developmental competence. Hum Reprod. 2002 Dec;17(12):3129-37. doi: 10.1093/humrep/17.12.3129.
PubMed 12456612Wu KK, Papp AC, Manner CE, Hall ER. Interaction between lymphocytes and platelets in the synthesis of prostacyclin. J Clin Invest. 1987 Jun;79(6):1601-6. doi: 10.1172/JCI112995.
PubMed 3108319Kan O, Simsir C, Atabekoglu CS, Sonmezer M. The impact of adding hp-hMG in r-FSH started GnRH antagonist cycles on ART outcome. Gynecol Endocrinol. 2019 Oct;35(10):869-872. doi: 10.1080/09513590.2019.1600667. Epub 2019 Apr 11.
PubMed 30973022Propst AM, Hill MJ, Bates GW, Palumbo M, Van Horne AK, Retzloff MG. Low-dose human chorionic gonadotropin may improve in vitro fertilization cycle outcomes in patients with low luteinizing hormone levels after gonadotropin-releasing hormone antagonist administration. Fertil Steril. 2011 Oct;96(4):898-904. doi: 10.1016/j.fertnstert.2011.06.069. Epub 2011 Aug 11.
PubMed 21839437Tayyar AT, Kahraman S. Comparison between cycles of the same patients when using recombinant luteinizing hormone + recombinant follicle stimulating hormone (rFSH), human menopausal gonadotropin + rFSH and rFSH only. Arch Med Sci. 2019 May;15(3):673-679. doi: 10.5114/aoms.2017.72408. Epub 2018 Jan 8.
PubMed 31110533Fleming R, Rehka P, Deshpande N, Jamieson ME, Yates RW, Lyall H. Suppression of LH during ovarian stimulation: effects differ in cycles stimulated with purified urinary FSH and recombinant FSH. Hum Reprod. 2000 Jul;15(7):1440-5. doi: 10.1093/humrep/15.7.1440.
PubMed 10875848Westergaard LG, Laursen SB, Andersen CY. Increased risk of early pregnancy loss by profound suppression of luteinizing hormone during ovarian stimulation in normogonadotrophic women undergoing assisted reproduction. Hum Reprod. 2000 May;15(5):1003-8. doi: 10.1093/humrep/15.5.1003.
PubMed 10783342Alviggi C, Clarizia R, Mollo A, Ranieri A, De Placido G. Outlook: who needs LH in ovarian stimulation? Reprod Biomed Online. 2006 May;12(5):599-607. doi: 10.1016/s1472-6483(10)61186-8.
PubMed 16790105Li F, Ye T, Kong H, Li J, Hu L, Jin H, Su Y, Li G. Efficacies of different ovarian hyperstimulation protocols in poor ovarian responders classified by the POSEIDON criteria. Aging (Albany NY). 2020 May 29;12(10):9354-9364. doi: 10.18632/aging.103210. Epub 2020 May 29.
PubMed 32470947
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07128394
- Acronym / sponsor ID
- ELH-IVF / SZ-ELH-2025
- Conditions
- Infertility, Female, Luteinizing Hormone (LH)
- Keywords
- Luteinizing Hormone, Long GnRH Agonist Protocol, Excessive LH Suppression, Controlled Ovarian Stimulation, In Vitro Fertilization, Embryo Quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 19 Aug 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.
This randomized controlled trial aims to evaluate whether supplementation with exogenous luteinizing hormone (LH) can improve embryo quality in patients undergoing in vitro fertilization (IVF) with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol who have excessive suppression of LH. Eligible participants will be randomly assigned to receive either exogenous LH supplementation or standard care. The primary outcome is embryo quality, and secondary outcomes include pregnancy rates and safety assessments. The study is conducted at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University.
Detailed description
Excessive suppression of luteinizing hormone (LH) during ovarian stimulation with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol has been associated with suboptimal follicular development, impaired oocyte maturation, and reduced embryo quality. LH plays a critical role in the final stages of folliculogenesis, steroidogenesis, and ovulation, and its deficiency during controlled ovarian hyperstimulation may adversely affect the developmental competence of oocytes.
This randomized controlled trial is designed to evaluate whether supplementation with exogenous LH can improve embryo quality in patients undergoing in vitro fertilization (IVF) with excessive LH suppression during a long GnRH-a protocol. Eligible participants are women meeting predefined hormonal suppression criteria prior to or during stimulation. Participants will be randomly assigned to receive either exogenous LH supplementation in addition to standard ovarian stimulation or standard care without LH supplementation.
The primary endpoint is the proportion of high-quality embryos obtained per cycle. Secondary endpoints include clinical pregnancy rate, implantation rate, live birth rate, and safety outcomes such as incidence of ovarian hyperstimulation syndrome (OHSS) and adverse events.
The study aims to provide high-quality evidence to guide the optimal management of patients with profound LH suppression during controlled ovarian stimulation. Findings from this trial may contribute to refining stimulation protocols and improving reproductive outcomes in assisted reproductive technology (ART).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving exogenous luteinizing hormone (LH) supplementation in addition to the standard long GnRH agonist protocol, or the control group receiving the standard long GnRH agonist protocol without LH supplementation. Both groups will undergo controlled ovarian stimulation and in vitro fertilization (IVF) according to the study protocol.
| Arm | Type | Receives |
|---|---|---|
| Recombinant LH Supplementation Group | Experimental | Drug: Recombinant Luteinizing Hormone (rLH), Drug: Recombinant Follicle-Stimulating Hormone (rFSH), Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a)Participants receive controlled ovarian hyperstimulation (COH) using a long-acting GnRH agonist (triptorelin 3.75 mg) for pituitary downregulation, followed by recombinant FSH (rFSH) combined with recombinant LH (rLH) at a ratio of 2:1 starting on stimulation day. rLH administration continues throughout the stimulation phase, with gonadotropin doses adjusted based on follicular growth and hormone monitoring. Trigger is given when 2-3 leading follicles reach ≥18 mm, followed by oocyte retrieval, IVF/ICSI, and embryo quality assessment. |
| Conventional rFSH-Only Group | Active comparator | Drug: Recombinant Follicle-Stimulating Hormone (rFSH), Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a)Participants receive the same long-acting GnRH agonist downregulation and rFSH stimulation protocol as the experimental arm, but without rLH supplementation. Only rFSH is used during COH, with dose adjustments according to follicular development and hormone levels. Trigger, oocyte retrieval, IVF/ICSI, and embryo assessment follow the same procedures as in the experimental arm. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 20 to 37 years (inclusive). Diagnosed with infertility and undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment using the long-acting GnRH agonist protocol.
- Serum luteinizing hormone (LH) level <0.5 U/L after pituitary downregulation. Normal uterine cavity as confirmed by hysteroscopy, sonohysterography, or hysterosalpingography within 6 months.
- Written informed consent provided prior to participation.
Key exclusion criteria (3 listed)
- Polycystic ovary syndrome (PCOS). History of recurrent implantation failure (RIF). Presence of endometriosis or adenomyosis. History of ovarian surgery. Ovarian cysts ≥3 cm or with suspected malignancy. Poor ovarian reserve (antral follicle count <5, anti-Müllerian hormone <1.1 ng/mL, or baseline FSH >10 IU/L).
- Chromosomal abnormalities in either partner. Systemic diseases such as uncontrolled hypertension, diabetes, thyroid disorders, or autoimmune diseases.
- Contraindications to ovarian stimulation medications or pregnancy.
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 |
|---|---|---|
| Recombinant Luteinizing Hormone (rLH)Also: lutropin alfa, LuverisRecombinant LH administered subcutaneously in combination with recombinant FSH (rFSH) at a ratio of 2:1 starting on stimulation day, continued throughout controlled ovarian hyperstimulation. Dosage adjusted according to follicular growth and serum hormone levels. | Drug | Recombinant LH Supplementation Group |
| Recombinant Follicle-Stimulating Hormone (rFSH)Also: follitropin alfa, Gonal-FRecombinant FSH administered subcutaneously for controlled ovarian hyperstimulation after pituitary downregulation with a long-acting GnRH agonist. Dosage adjusted based on follicular development and hormone monitoring. | Drug | Conventional rFSH-Only Group, Recombinant LH Supplementation Group |
| Gonadotropin-Releasing Hormone Agonist (GnRH-a)Also: triptorelin, DipherelineLong-acting GnRH agonist (3.75 mg) administered subcutaneously on menstrual cycle day 2-4 for pituitary downregulation before controlled ovarian hyperstimulation. | Drug | Conventional rFSH-Only Group, Recombinant LH Supplementation Group |
Primary outcome
Proportion of cycles with no usable embryos
Time frame: 7 days after oocyte retrieval
The number of IVF/ICSI cycles with no transferable embryos divided by the total number of oocyte retrieval cycles, evaluated based on embryo morphology and grading on Day 3 or Day 5-6 after fertilization.
7 secondary outcomes
Number of high-quality Day 3 embryos
Time frame: 7 days after oocyte retrieval
Total gonadotropin dose used
Time frame: At the end of ovarian stimulation (average 8-12 days)
Duration of gonadotropin stimulation
Time frame: At the end of ovarian stimulation (average 8-12 days)
Number of oocytes retrieved
Time frame: At oocyte retrieval (36-38 hours after trigger)
Clinical pregnancy rate
Time frame: 30 days after embryo transfer
Early miscarriage rate
Time frame: Within 12 weeks of gestation
Live birth rate
Time frame: At delivery (up to 1 year after embryo transfer)
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 19 Aug 2025.
- Background: PubMed 25237892Yazici Yilmaz F, Gorkemli H, Colakoglu MC, Aktan M, Gezginc K. The evaluation of recombinant LH supplementation in patients with suboptimal response to recombinant FSH undergoing IVF treatment with GnRH agonist down-regulation. Gynecol Endocrinol. 2015 Feb;31(2):141-4. doi: 10.3109/09513590.2014.965675. Epub 2014 Sep 19.
- Background: PubMed 12456612Tesarik J, Mendoza C. Effects of exogenous LH administration during ovarian stimulation of pituitary down-regulated young oocyte donors on oocyte yield and developmental competence. Hum Reprod. 2002 Dec;17(12):3129-37. doi: 10.1093/humrep/17.12.3129.
- Background: PubMed 3108319Wu KK, Papp AC, Manner CE, Hall ER. Interaction between lymphocytes and platelets in the synthesis of prostacyclin. J Clin Invest. 1987 Jun;79(6):1601-6. doi: 10.1172/JCI112995.
- Background: PubMed 30973022Kan O, Simsir C, Atabekoglu CS, Sonmezer M. The impact of adding hp-hMG in r-FSH started GnRH antagonist cycles on ART outcome. Gynecol Endocrinol. 2019 Oct;35(10):869-872. doi: 10.1080/09513590.2019.1600667. Epub 2019 Apr 11.
- Background: PubMed 21839437Propst AM, Hill MJ, Bates GW, Palumbo M, Van Horne AK, Retzloff MG. Low-dose human chorionic gonadotropin may improve in vitro fertilization cycle outcomes in patients with low luteinizing hormone levels after gonadotropin-releasing hormone antagonist administration. Fertil Steril. 2011 Oct;96(4):898-904. doi: 10.1016/j.fertnstert.2011.06.069. Epub 2011 Aug 11.
- Background: PubMed 31110533Tayyar AT, Kahraman S. Comparison between cycles of the same patients when using recombinant luteinizing hormone + recombinant follicle stimulating hormone (rFSH), human menopausal gonadotropin + rFSH and rFSH only. Arch Med Sci. 2019 May;15(3):673-679. doi: 10.5114/aoms.2017.72408. Epub 2018 Jan 8.
- Background: PubMed 10875848Fleming R, Rehka P, Deshpande N, Jamieson ME, Yates RW, Lyall H. Suppression of LH during ovarian stimulation: effects differ in cycles stimulated with purified urinary FSH and recombinant FSH. Hum Reprod. 2000 Jul;15(7):1440-5. doi: 10.1093/humrep/15.7.1440.
- Background: PubMed 10783342Westergaard LG, Laursen SB, Andersen CY. Increased risk of early pregnancy loss by profound suppression of luteinizing hormone during ovarian stimulation in normogonadotrophic women undergoing assisted reproduction. Hum Reprod. 2000 May;15(5):1003-8. doi: 10.1093/humrep/15.5.1003.
- Background: PubMed 16790105Alviggi C, Clarizia R, Mollo A, Ranieri A, De Placido G. Outlook: who needs LH in ovarian stimulation? Reprod Biomed Online. 2006 May;12(5):599-607. doi: 10.1016/s1472-6483(10)61186-8.
- Background: PubMed 32470947Li F, Ye T, Kong H, Li J, Hu L, Jin H, Su Y, Li G. Efficacies of different ovarian hyperstimulation protocols in poor ovarian responders classified by the POSEIDON criteria. Aging (Albany NY). 2020 May 29;12(10):9354-9364. doi: 10.18632/aging.103210. Epub 2020 May 29.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to concerns regarding patient privacy, confidentiality, and compliance with local regulations.
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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.
慧 Jiang, PhD principal investigator
Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Luteinizing Hormone (rLH), Recombinant Follicle-Stimulating Hormone (rFSH) and Gonadotropin-Releasing Hormone Agonist (GnRH-a) in people with Infertility, Female and Luteinizing Hormone (LH), run by Nanjing University at 1 site in China.
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 3 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 19 Aug 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 China. 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?
Contact Yue Jiang, PhD (+8613814122872, jiangyue85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of cycles with no usable embryos (time frame: 7 days after oocyte retrieval). 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 NCT07128394, which also lists 10 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 19 Aug 2025.