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Trial · Interventional

RecruitingPhase 3Registry data

Luteal Phase Support With GnRH Agonist After GnRH Agonist Triggering in IVF/ICSI Cycles

Short name SOLOAGO

NCTNCT06150703 (opens ClinicalTrials.gov in a new tab)Other idAPHP220667
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
652 participants (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Design
Randomized · Open label (no masking)
Countries
1 country

France

Start
27 Jun 2024
Primary completion
Sept 2027 (estimated)
Completion
27 Sept 2027 (estimated)
First posted
29 Nov 2023
Last update posted
24 Aug 2025
Conditions
In Vitro Fertilization · ICSI Intracytoplasmic Spermatozoid Injection

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20242025202620272028
  1. Ph 3

    SOLOAGO

    NCT06150703

    27 Jun 2024 to est. 27 Sept 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • Ovulation induction with hCG + Luteal phase support with vaginal progesteroneDrug
  • Ovulation triggering by Triptorelin + Luteal phase support by NafarelinDrug

Arms2

  • Active comparator

    Ovulation triggering with hCG + Luteal phase support with vaginal progesterone

    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

  • Experimental

    Ovulation triggering with Triptorelin + Luteal phase support with Nafarelin

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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

Secondary outcomes(20)

  1. Embryo implantation defined as the presence of a gestational sac on the first ultrasound (5-8 WG)

    Time frame · 5-8 weeks' gestation

    Registry description

    Demonstrate improvement of embryo implantation rates with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  2. Pregnancy defined as an hCG level > 10 IU/ml 14 days after oocyte retrieval.

    Time frame · 14 days after oocyte retrieval.

    Registry description

    Demonstrate an improvement in pregnancy rate with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  3. 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

    Registry description

    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.

  4. Miscarriage prior to 12 WG, defined as the termination of a pregnancy prior to 12 WG.

    Time frame · 12 weeks' gestation

    Registry description

    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.

  5. 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)

    Registry description

    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.

  6. Number of patients with gravidic hypertension and its onset,

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  7. Number of patients with pre-eclampsia and its onset,

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  8. Number of patients with gestational diabetes and its onset

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  9. Number of patients with term and mode of delivery

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  10. Number of patients with medical termination of pregnancy

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  11. Number of patients with late miscarriage (between 12 and 22 WG)

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  12. Number of patients with fetal death in utero

    Time frame · between 12 weeks of gestation and 22 weeks of gestation

    Registry description

    Compare the impact on obstetric data with GnRHa triggering and GnRHa luteal phase support compared to hCG induction and exogenous vaginal progesterone luteal support.

  13. 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

    Registry description

    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.

  14. Progesterone levels on day of oocyte pick up and at Day 7 post oocyte pick up.

    Time frame · Day 7 post oocyte pick up

    Registry description

    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.

  15. Estradiol levels on day of oocyte pick up and at Day 7 post oocyte pick up.

    Time frame · Day 7 post oocyte pick up

    Registry description

    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.

  16. LH levels on day of oocyte pick up and at Day 7 post oocyte pick up.

    Time frame · Day 7 post oocyte pick up

    Registry description

    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.

  17. hCG levels on day of oocyte pick up and at Day 7 post oocyte pick up.

    Time frame · Day 7 post oocyte pick up

    Registry description

    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.

  18. Progesterone levels during follow-up, presence of pregnancy and presence of miscarriage.

    Time frame · 19 months

    Registry description

    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.

  19. Estradiol levels during follow-up, presence of pregnancy and presence of miscarriage.

    Time frame · 19 months

    Registry description

    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.

  20. LH levels during follow-up, presence of pregnancy and presence of miscarriage.

    Time frame · 19 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 39 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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 * 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

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