Infertility (IVF Patients)REWAGNCT06995261
Follitropin Delta in Long GnRH-agonist Protocol
An observational study of Infertility (IVF Patients) and Infertility, run by Prof. Dr. med. M.Sc. Georg Griesinger at 4 sites in Germany.
Trial summary
The REWAG study ("Real-world Evaluation of Women undergoing Agonist protocol with Follitropin delta") is a non-interventional observational study conducted across several fertility centers in Germany. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility (IVF Patients), Infertility, Infertility Drugs
- How many people
- 350 participants
- Where
- 4 sitesGermany
- Study dates
- 9 Jul 2025to Dec 2027
- Phase
- Observational
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women undergoing IVF oder ICSI. This study is intended to be conducted in non-vulnerable population. No vulnerable subjects will be enrolled in the study.
Who may be able to join
- Age ≥18 to ≤ 44 years at enrolment
- Planned stimulation in a long luteal GnRH agonist protocol with daily s.c. GnRH-agonist
- Planned use of Fd for ovarian stimulation as per SmPC
- Serum AMH ≥0.3 ng/ml to ≤4.9 ng/ml measured within12 months prior to treatment
- Most recent serum AMH value before start of stimulation not older than 12 months
- Planned IVF or ICSI treatment in a first or second attempt with ejaculated or cryopreserved male germ cells, autologous or heterologous, with or without planned genetic testing of the oocytes or embryos
- Planned triggering of final oocyte maturation with hCG
- Willingness and consent to participate
Who cannot join
- Serum AMH value not determined in ELECSYS AMH Plus Immunoassay, ACCESS AMH Advanced (Beckham Coulter) or LUMIPULSE G AMH (Fujirebio)
- Most recent serum AMH value before start of stimulation older than 12 months
- Serum AMH within 12 months prior to treatment AMH ≤ 0.3 ng/ml or ≥4.9 ng/ml measured within 12 months prior to treatment
- Pre-treatment with a combined oral contraceptive "pill" consisting of ethinyl estradiol and a synthetic progestogen or a natural estradiol/progesterone
- Anovulatory PCOS syndrome
- Women with a contraindication for prescription of Fd treatment
- Women undergoing ovarian stimulation for fertility preservation
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Recruiting
Department of Obstetrics, Gynecology and Reproductive Endocrinology (UniKiD), Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Alexandra Bielfeld, MD, PhD, +49 211 81 04060, Alexandra.Bielfeld@med.uni-duesseldorf.de
Jan Krüssel, MD, PhD, +49 211 81 04060, jan-steffen.kruessel@med.uni-duesseldorf.de
- Recruiting
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
Sören von Otte, MD, PhD, +49 431 500 92220, soeren.vonOtte@uksh.de
- Recruiting
Department of Reproductive Medicine and Gynecological Endocrinology, University Hospital of Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Georg Griesinger, MD, + 49 451 505 778 212, georg.griesinger@uni-luebeck.de
Lilit Kamalyan, MD, PhD, +49 451 505 778 212, lilit.kamalyan@uksh.de
- Recruiting
Center for Reproductive Medicine, IVF SAAR
Saarbrücken, Saarland, 66113
Sascha Tauchert, MD, +49 681 93632 0, S.Tauchert@ivf-saar.de
About this study
Official title: The Performance of an Individual Dosing Regimen of Follitropin Delta (Fd) in a GnRH Agonist Protocol for Controlled Ovarian Stimulation for IVF/ICSI in a Real-word Setting: a Non-interventional Cohort Study
The REWAG study ("Real-world Evaluation of Women undergoing Agonist protocol with Follitropin delta") is a non-interventional observational study conducted across several fertility centers in Germany. The goal of this study is to evaluate how well a personalized dosing regimen of a hormone called Follitropin delta works in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a long GnRH agonist protocol.
Follitropin delta is a recombinant follicle-stimulating hormone (rFSH) that allows for individualized dosing based on a woman's weight and a blood marker called anti-Müllerian hormone (AMH). This personalized approach may help to better balance the stimulation of the ovaries, aiming to reduce the risk of overstimulation (OHSS) while still achieving good treatment outcomes.
Read more
The study will include approximately 350 women who are undergoing routine IVF/ICSI treatment. No experimental drugs or procedures are involved. All treatment decisions remain the responsibility of the attending physicians and follow standard clinical practice. Data will be collected only from routine visits and medical documentation, with no additional interventions required for participation.
Researchers will analyze outcomes such as the number of eggs retrieved, pregnancy rates, treatment cancellations, and any side effects. The study will also look at whether certain patient characteristics can predict how well the treatment works or whether complications may arise.
Participation is voluntary. All personal data will be pseudonymized and handled according to strict data protection regulations (GDPR). Results will help to improve understanding of how personalized hormone dosing performs in real-life settings and may support more tailored and effective fertility treatments in the future.
- Conditions
- Infertility (IVF Patients), Infertility, Infertility Drugs
- Keywords
- follitropin delta, Rekovelle, Long GnRH-agonist protocol, individualized ovarian stimulation, Dosing algorithm, FSH
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Follitropin Delta in Long GnRH Agonist Protocol | This cohort includes women undergoing controlled ovarian stimulation for IVF or ICSI treatment using Follitropin delta administered in a long GnRH agonist protocol. The dosing is individualized based on AMH serum levels and body weight. Participants are treated according to routine clinical practice, and no study drug is provided. The study is non-interventional. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovarian Hyperstimulation Syndrome (OHSS)
Ovarian Hyperstimulation Syndrome (OHSS) of any grade and any onset by Golan classification
Measured: From oocyte pick-up to gestational week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start9 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. M.Sc. Georg Griesinger
- Sponsor type
- University, hospital or other
- Collaborators
- University Hopsital Schleswig Holstein Campus Lübeck
- Responsible party
- Sponsor-investigator, Prof. Dr. med. M.Sc. Georg Griesinger, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995261
- Sponsor's protocol ID
- 2025-123 EC Luebeck
- Acronym
- REWAG
- Status last verified
- Jul 2025
- First submitted
- 20 May 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print.
PubMed 38723189
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of an Individual Dosing Regimen of Follitropin Delta (Fd) in a GnRH Agonist Protocol for Controlled Ovarian Stimulation for IVF/ICSI in a Real-word Setting: a Non-interventional Cohort Study
- ClinicalTrials.gov ID
- NCT06995261
- Acronym / sponsor ID
- REWAG / 2025-123 EC Luebeck
- Conditions
- Infertility (IVF Patients), Infertility, Infertility Drugs
- Keywords
- follitropin delta, Rekovelle, Long GnRH-agonist protocol, individualized ovarian stimulation, Dosing algorithm, FSH
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Prof. Dr. med. M.Sc. Georg GriesingerUniversity, hospital or other
- Collaborators
- University Hopsital Schleswig Holstein Campus Lübeck
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The REWAG study ("Real-world Evaluation of Women undergoing Agonist protocol with Follitropin delta") is a non-interventional observational study conducted across several fertility centers in Germany. The goal of this study is to evaluate how well a personalized dosing regimen of a hormone called Follitropin delta works in women undergoing controlled ovarian stimulation (COS) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using a long GnRH agonist protocol.
Follitropin delta is a recombinant follicle-stimulating hormone (rFSH) that allows for individualized dosing based on a woman's weight and a blood marker called anti-Müllerian hormone (AMH). This personalized approach may help to better balance the stimulation of the ovaries, aiming to reduce the risk of overstimulation (OHSS) while still achieving good treatment outcomes.
The study will include approximately 350 women who are undergoing routine IVF/ICSI treatment. No experimental drugs or procedures are involved. All treatment decisions remain the responsibility of the attending physicians and follow standard clinical practice. Data will be collected only from routine visits and medical documentation, with no additional interventions required for participation.
Researchers will analyze outcomes such as the number of eggs retrieved, pregnancy rates, treatment cancellations, and any side effects. The study will also look at whether certain patient characteristics can predict how well the treatment works or whether complications may arise.
Participation is voluntary. All personal data will be pseudonymized and handled according to strict data protection regulations (GDPR). Results will help to improve understanding of how personalized hormone dosing performs in real-life settings and may support more tailored and effective fertility treatments in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Follitropin Delta in Long GnRH Agonist Protocol | – | –This cohort includes women undergoing controlled ovarian stimulation for IVF or ICSI treatment using Follitropin delta administered in a long GnRH agonist protocol. The dosing is individualized based on AMH serum levels and body weight. Participants are treated according to routine clinical practice, and no study drug is provided. The study is non-interventional. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women undergoing IVF oder ICSI. This study is intended to be conducted in non-vulnerable population. No vulnerable subjects will be enrolled in the study.
Key inclusion criteria (8 listed)
- Age ≥18 to ≤ 44 years at enrolment
- Planned stimulation in a long luteal GnRH agonist protocol with daily s.c. GnRH-agonist
- Planned use of Fd for ovarian stimulation as per SmPC
- Serum AMH ≥0.3 ng/ml to ≤4.9 ng/ml measured within12 months prior to treatment
- Most recent serum AMH value before start of stimulation not older than 12 months
Key exclusion criteria (7 listed)
- Serum AMH value not determined in ELECSYS AMH Plus Immunoassay, ACCESS AMH Advanced (Beckham Coulter) or LUMIPULSE G AMH (Fujirebio)
- Most recent serum AMH value before start of stimulation older than 12 months
- Serum AMH within 12 months prior to treatment AMH ≤ 0.3 ng/ml or ≥4.9 ng/ml measured within 12 months prior to treatment
- Pre-treatment with a combined oral contraceptive "pill" consisting of ethinyl estradiol and a synthetic progestogen or a natural estradiol/progesterone
- Anovulatory PCOS syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: From oocyte pick-up to gestational week 20
Ovarian Hyperstimulation Syndrome (OHSS) of any grade and any onset by Golan classification
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 Jul 2025.
- Background: PubMed 38723189Lobo R, Soerdal T, Ekerhovd E, Cohlen B, Porcu E, Schenk M, Shufaro Y, Smeenk J, Suerdieck MB, Pinton P, Pinborg A; BEYOND Investigators. BEYOND: a randomized controlled trial comparing efficacy and safety of individualized follitropin delta dosing in a GnRH agonist versus antagonist protocol during the first ovarian stimulation cycle. Hum Reprod. 2024 May 9;39(7):1481-94. doi: 10.1093/humrep/deae092. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility (IVF Patients) and Infertility, run by Prof. Dr. med. M.Sc. Georg Griesinger at 4 sites in Germany.
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 7 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 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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 Georg Griesinger, MD (+49 451 505 778 212, georg.griesinger@uni-luebeck.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ovarian Hyperstimulation Syndrome (OHSS) (time frame: From oocyte pick-up to gestational week 20). 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 NCT06995261, which also lists 1 linked publication.
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 Jul 2025.