In Vitro FertilizationPhase 3SOLOAGONCT06150703
Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles
A Phase 3 study testing Ovulation induction with hCG + Luteal phase support with vaginal progesterone and Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin in people with In Vitro Fertilization and ICSI Intracytoplasmic Spermatozoid Injection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- In Vitro Fertilization, ICSI Intracytoplasmic Spermatozoid Injection
- What is being tested?
- Ovulation induction with hCG + Luteal phase support with vaginal progesterone and Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 652 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2024to 27 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.
- Patients aged 18 to 39 included
- First or second attempt at IVF or ICSI for pregnancy
- BMI < 35 kg/m2
- Anti-Mullerian hormone (AMH) > 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 within the year prior to inclusion
- AMH < 5 ng/ml and/or antral follicle count <40 within the year prior to inclusion
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- Treatment with recombinant FSH
- Antagonist protocol (with pre-treatment or not)
- Initial dose of recombinant FSH between 75 and 450 IU
- Signed informed consent
- Affiliation to the social security system (excluding AME)
Who cannot join
- Patient diagnosed with HIV infection
- ICSI with sperm from testicular biopsy
- Pre-implantation diagnosis
- Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH <1.2 IU/L)
- History of severe ovarian hyperstimulation syndrome (OHSS)
- Unoperated hydrosalpinx
Show all 20Show fewer
- Intracavitary polyps or myomas deforming the cavity
- Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, Sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soybean lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid).
- Gynaecological bleeding or genital haemorrhage
- History of epilepsy and/or intracranial tumors potentially causing epilepsy
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement or cysts unrelated to polycystic ovary syndrome
- Severe adenomyosis requiring a long protocol
- Carcinoma of the ovary, uterus or breast
- Active thromboembolic events
- Severe impairment of liver function
- Breastfeeding women
- Patients under court protection, guardianship or curators
- Current participation in another therapeutic interventional trial on the day of inclusion
- Patients who do not speak or understand French
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Maeliss Peigné
Bondy
Maeliss Peigné, 0148026856, maeliss.peigne@aphp.fr
About this study
Official title: Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial
The development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).
Read the detailed description
It is currently established that obtaining a large number of oocytes is a key of success in IVF/ICSI cycles. However, it is also a risk factor for ovarian hyperstimulation syndrome (OHSS) and a risk factor of implantation failure after fresh embryo transfer because of the alteration of endometrial receptivity. A freeze all strategy can be proposed to avoid these risks but vitrification of embryos, although more efficient than slow freezing in terms of embryo survival, is not without risk. Furthermore, proper endometrial and embryo timing for frozen-thawed embryo transfer is still debated.
Recent preliminary works suggest another possible way to combine an optimal ovarian response with the recovery of a large number of oocytes, good chances of implantation and a reduced risk of OHSS. To achieve this goal, ovulation triggering and luteal phase support need to be modified together. The human chorionic gonadotropin (hCG) (mimicking the Luteinising Hormone (LH)peak to trigger ovulation) that induces OHSS is replaced by an a GnRH agonist (GnRHa) triggering allowing an endogenous peak of Follicle Stimulating Hormone (FSH) and LH. Then, the usual support of the luteal phase by exogenous vaginal progesterone, whose absorption seems to be suboptimal for about 30% of patients, is replaced by endogenous progesterone production by the corpora lutea, supported by the maintenance of LH activity through the continuation of agonist of gonadotropin releasing hormone (AgoGnRH) in the luteal phase. Pilot studies show that a 10% to 15% increase in ongoing pregnancy rates can be expected with this type of protocol. The objective of our study is to demonstrate an increase in ongoing pregnancy rate per cycle with this new strategy combining GnRHa triggering and GnRHa luteal phase support compared to the reference protocol (hCG triggering and exogenous progesterone luteal phase support).
- Being tested
- Ovulation induction with hCG + Luteal phase support with vaginal progesterone, Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin
- Keywords
- GnRH agonist triggering, GnRH agonist luteal phase support,, pregnancy, live birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovulation induction with hCG + Luteal phase support with vaginal progesteroneDrug
hCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg/d (200mg morning, noon and evening) vaginally from the evening of the puncture until the pregnancy test result
Ovulation triggering by Triptorelin + Luteal phase support by NafarelinDrug
Triptorelin 0.2 mg subcutaneously between 36h and 38h before oocyte retrieval as a single dose Nafarelin 400µg /day (200µg in the morning 200µg in the evening) nasally from the evening of the oocyte retrieval until the first pregnancy test
| Study group | Role | What they receive |
|---|---|---|
| Ovulation triggering with hCG + Luteal phase support with vaginal progesterone | Active comparator | hCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg/d (200mg tid) vaginally from the evening of the oocyte retrieval until the first pregnancy test Receives: Drug: Ovulation induction with hCG + Luteal phase support with vaginal progesterone |
| Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin | Experimental | Triptorelin 0.2 mg subcutaneously between 36h and 38h before oocyte retrieval as a single dose Nafarelin 400µg /day (200µg in the morning 200µg in the evening) nasally from the evening of the oocyte retrieval until the first pregnancy test Receives: Drug: Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth, defined as the presence of a live birth after 22 weeks' gestation. Twin pregnancies will be counted as a single birth.
To demonstrate an increase in the rate of live births after 22 weeks' amenorrhoea (SA) per cycle with induction and support by GnRH agonist compared with the reference protocol combining induction by hCG and luteal support by exogenous vaginal progesterone
Measured: 22 weeks' gestation
Secondary outcomes (29)
Embryo implantation defined as the presence of a gestational sac on the first ultrasound (5-8 WG)
Demonstrate improvement of embryo implantation rates with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5-8 weeks' gestation
Pregnancy defined as an hCG level > 10 IU/ml 14 days after oocyte retrieval.
Demonstrate an improvement in pregnancy rate with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 14 days after oocyte retrieval.
Clinical pregnancy, defined as an intrauterine gestational sac with embryo showing cardiac activity on ultrasound at 5-10 WG
Demonstrate an improvement in clinical pregnancy rate with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5-10 weeks' gestation
Miscarriage prior to 12 WG, defined as the termination of a pregnancy prior to 12 WG.
Demonstrate a decrease in the rate of miscarriage per pregnancy with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 12 weeks' gestation
Ongoing pregnancy, defined as the presence of an intra-uterine sac with an embryo with cardiac activity visible on ultrasound between 11 weeks of gestations(WG) and 13 WG+6 days (first trimester ultrasound).
Demonstrate an increase ongoing pregnancy rate at 12 weeks of gestation (12 WG) per cycle with GnRHa triggering and GnRHa luteal phase support compared with the reference protocol: hCG triggering and exogenous vaginal progesterone luteal phase support.
Measured: first trimester ultrasound (11 weeks of gestation and 13weeks of gestation +6days)
Number of patients with gravidic hypertension and its onset,
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with pre-eclampsia and its onset,
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with gestational diabetes and its onset
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with term and mode of delivery
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with medical termination of pregnancy
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with late miscarriage (between 12 and 22 WG)
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with fetal death in utero
Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: between 12 weeks of gestation and 22 weeks of gestation
Ovarian hyperstimulation syndrome, defined as the presence of moderate to severe syndrome, early and late. Early defined as the period before D10 post retrieval and late defined as pregnancy related OHSS, after D10 post oocyte retrieval
Demonstrate a decrease in the rate of moderate to severe and early and late OHSS with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: before Day 10 post retrieval and after Day 10 post oocyte retrieval
Progesterone levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Compare the evolution of the corpus luteum in the luteal phase with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: Day 7 post oocyte pick up
Estradiol levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Compare the evolution of the corpus luteum in the luteal phase with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: Day 7 post oocyte pick up
LH levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Compare the evolution of the corpus luteum in the luteal phase with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: Day 7 post oocyte pick up
hCG levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Compare the evolution of the corpus luteum in the luteal phase with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: Day 7 post oocyte pick up
Progesterone levels during follow-up, presence of pregnancy and presence of miscarriage.
Assess the association of progesterone levels with pregnancy and miscarriage throughout follow-up with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 19 months
Estradiol levels during follow-up, presence of pregnancy and presence of miscarriage.
Assess the association of estradiol levels with pregnancy and miscarriage throughout follow-up with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 19 months
LH levels during follow-up, presence of pregnancy and presence of miscarriage.
Assess the association of LH levels with pregnancy and miscarriage throughout follow-up with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 19 months
hCG levels during follow-up, presence of pregnancy and presence of miscarriage.
Assess the association of hCG levels with pregnancy and miscarriage throughout follow-up with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 19 months
All adverse events up to delivery
Evaluate the side effects with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 19 months
Number of oocytes collected,
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: oocyte puncture visit
number of mature oocytes
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: oocyte puncture visit
number of oocytes fertilised,
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5th day post oocyte puncture visit
number of embryos on the second day of development,
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5th day post oocyte puncture visit
number of blastocysts obtained,
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5th day post oocyte puncture visit
number of blastocysts transferred,
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5th day post oocyte puncture visit
number of blastocysts frozen.
Compare embryonic development with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.
Measured: 5th day post oocyte puncture visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 Jun 2024
- Primary completionSep 2027 (estimated)
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 652 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150703
- Sponsor's protocol ID
- APHP220667
- Acronym
- SOLOAGO
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2023
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal Phase Support With GnRH Agonist Alone After GnRH Agonist Triggering and Fresh Embryo Transfer Compared to the Reference Protocol (hCG Triggering and Progesterone Luteal Support): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06150703
- Acronym / sponsor ID
- SOLOAGO / APHP220667
- Keywords
- GnRH agonist triggering, GnRH agonist luteal phase support,, pregnancy, live birth
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 29 Nov 2023 (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 development of stimulation protocols for in vitro fertilisation (IVF) has led to a paradox. It has now been established that obtaining a large number of oocytes is a key to success, but that it is also a risk factor for embryo transfer failure after puncture (disruption of endometrial receptivity due to luteal insufficiency) and a risk factor for complications such as ovarian hyperstimulation syndrome (OHSS).
Detailed description
It is currently established that obtaining a large number of oocytes is a key of success in IVF/ICSI cycles. However, it is also a risk factor for ovarian hyperstimulation syndrome (OHSS) and a risk factor of implantation failure after fresh embryo transfer because of the alteration of endometrial receptivity. A freeze all strategy can be proposed to avoid these risks but vitrification of embryos, although more efficient than slow freezing in terms of embryo survival, is not without risk. Furthermore, proper endometrial and embryo timing for frozen-thawed embryo transfer is still debated.
Recent preliminary works suggest another possible way to combine an optimal ovarian response with the recovery of a large number of oocytes, good chances of implantation and a reduced risk of OHSS. To achieve this goal, ovulation triggering and luteal phase support need to be modified together. The human chorionic gonadotropin (hCG) (mimicking the Luteinising Hormone (LH)peak to trigger ovulation) that induces OHSS is replaced by an a GnRH agonist (GnRHa) triggering allowing an endogenous peak of Follicle Stimulating Hormone (FSH) and LH. Then, the usual support of the luteal phase by exogenous vaginal progesterone, whose absorption seems to be suboptimal for about 30% of patients, is replaced by endogenous progesterone production by the corpora lutea, supported by the maintenance of LH activity through the continuation of agonist of gonadotropin releasing hormone (AgoGnRH) in the luteal phase. Pilot studies show that a 10% to 15% increase in ongoing pregnancy rates can be expected with this type of protocol. The objective of our study is to demonstrate an increase in ongoing pregnancy rate per cycle with this new strategy combining GnRHa triggering and GnRHa luteal phase support compared to the reference protocol (hCG triggering and exogenous progesterone luteal phase support).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovulation triggering with hCG + Luteal phase support with vaginal progesterone | Active comparator | Drug: Ovulation induction with hCG + Luteal phase support with vaginal progesteronehCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg/d (200mg tid) vaginally from the evening of the oocyte retrieval until the first pregnancy test |
| Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin | Experimental | Drug: Ovulation triggering by Triptorelin + Luteal phase support by NafarelinTriptorelin 0.2 mg subcutaneously between 36h and 38h before oocyte retrieval as a single dose Nafarelin 400µg /day (200µg in the morning 200µg in the evening) nasally from the evening of the oocyte retrieval until the first pregnancy test |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Patients requiring conventional IVF or IVF with sperm injection (ICSI) from the partner or donor under the conditions of management defined by French law.
- Patients aged 18 to 39 included
- First or second attempt at IVF or ICSI for pregnancy
- BMI < 35 kg/m2
- Anti-Mullerian hormone (AMH) > 1 ng/ml (= 7 pmol/L) and/or antral follicle count ≥ 8 within the year prior to inclusion
Key exclusion criteria (20 listed)
- Patient diagnosed with HIV infection
- ICSI with sperm from testicular biopsy
- Pre-implantation diagnosis
- Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH <1.2 IU/L)
- History of severe ovarian hyperstimulation syndrome (OHSS)
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 |
|---|---|---|
| Ovulation induction with hCG + Luteal phase support with vaginal progesteronehCG 250µg subcutaneously between 36h and 38h before oocyte retrieval + Progesterone 600mg/d (200mg morning, noon and evening) vaginally from the evening of the puncture until the pregnancy test result | Drug | Ovulation triggering with hCG + Luteal phase support with vaginal progesterone |
| Ovulation triggering by Triptorelin + Luteal phase support by NafarelinTriptorelin 0.2 mg subcutaneously between 36h and 38h before oocyte retrieval as a single dose Nafarelin 400µg /day (200µg in the morning 200µg in the evening) nasally from the evening of the oocyte retrieval until the first pregnancy test | Drug | Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin |
Primary outcome
Live birth, defined as the presence of a live birth after 22 weeks' gestation. Twin pregnancies will be counted as a single birth.
Time frame: 22 weeks' gestation
To demonstrate an increase in the rate of live births after 22 weeks' amenorrhoea (SA) per cycle with induction and support by GnRH agonist compared with the reference protocol combining induction by hCG and luteal support by exogenous vaginal progesterone
29 secondary outcomes
Embryo implantation defined as the presence of a gestational sac on the first ultrasound (5-8 WG)
Time frame: 5-8 weeks' gestation
Pregnancy defined as an hCG level > 10 IU/ml 14 days after oocyte retrieval.
Time frame: 14 days after oocyte retrieval.
Clinical pregnancy, defined as an intrauterine gestational sac with embryo showing cardiac activity on ultrasound at 5-10 WG
Time frame: 5-10 weeks' gestation
Miscarriage prior to 12 WG, defined as the termination of a pregnancy prior to 12 WG.
Time frame: 12 weeks' gestation
Ongoing pregnancy, defined as the presence of an intra-uterine sac with an embryo with cardiac activity visible on ultrasound between 11 weeks of gestations(WG) and 13 WG+6 days (first trimester ultrasound).
Time frame: first trimester ultrasound (11 weeks of gestation and 13weeks of gestation +6days)
Number of patients with gravidic hypertension and its onset,
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with pre-eclampsia and its onset,
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with gestational diabetes and its onset
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with term and mode of delivery
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with medical termination of pregnancy
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with late miscarriage (between 12 and 22 WG)
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Number of patients with fetal death in utero
Time frame: between 12 weeks of gestation and 22 weeks of gestation
Ovarian hyperstimulation syndrome, defined as the presence of moderate to severe syndrome, early and late. Early defined as the period before D10 post retrieval and late defined as pregnancy related OHSS, after D10 post oocyte retrieval
Time frame: before Day 10 post retrieval and after Day 10 post oocyte retrieval
Progesterone levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Time frame: Day 7 post oocyte pick up
Estradiol levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Time frame: Day 7 post oocyte pick up
LH levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Time frame: Day 7 post oocyte pick up
hCG levels on day of oocyte pick up and at Day 7 post oocyte pick up.
Time frame: Day 7 post oocyte pick up
Progesterone levels during follow-up, presence of pregnancy and presence of miscarriage.
Time frame: 19 months
Estradiol levels during follow-up, presence of pregnancy and presence of miscarriage.
Time frame: 19 months
LH levels during follow-up, presence of pregnancy and presence of miscarriage.
Time frame: 19 months
hCG levels during follow-up, presence of pregnancy and presence of miscarriage.
Time frame: 19 months
All adverse events up to delivery
Time frame: 19 months
Number of oocytes collected,
Time frame: oocyte puncture visit
number of mature oocytes
Time frame: oocyte puncture visit
number of oocytes fertilised,
Time frame: 5th day post oocyte puncture visit
number of embryos on the second day of development,
Time frame: 5th day post oocyte puncture visit
number of blastocysts obtained,
Time frame: 5th day post oocyte puncture visit
number of blastocysts transferred,
Time frame: 5th day post oocyte puncture visit
number of blastocysts frozen.
Time frame: 5th day post oocyte puncture visit
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 24 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ovulation induction with hCG + Luteal phase support with vaginal progesterone and Ovulation triggering by Triptorelin + Luteal phase support by Nafarelin in people with In Vitro Fertilization and ICSI Intracytoplasmic Spermatozoid Injection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 11 inclusion and 20 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 24 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 France. 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 Maeliss Peigné, MCU-PH (01 48 02 68 56, maeliss.peigne@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth, defined as the presence of a live birth after 22 weeks' gestation. Twin pregnancies will be counted as a single birth. (time frame: 22 weeks' gestation). 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 24 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.