Ovarian transplant update: Authors of 2004 live-birth follow-up letter ask Lancet to retract it

Yesterday, we brought you news of a story in Belgium involving questions about whether a woman who gave birth following an ovarian transplant could have become pregnant without the transplant. The case, which led to a university investigation but no retraction, included allegations of theft and arson.

This morning, we were made aware of a request for a retraction from The Lancet related to other work by Jacques Donnez, the obstetrician-gynecologist at the center of the case. In 2004, Donnez and colleagues published what they said was the first pregnancy using frozen banked ovarian tissue in The Lancet. The paper has been cited hundreds of times, but not everyone agreed with Donnez et al’s assessment at the time. All but one of the authors of a Lancet letter — colleagues of Donnez’s at the Catholic University of Louvain — describing the perinatal follow-up of the woman now say they don’t either, and want to retract their letter.

In their letter requesting retraction, published in the journal on July 14, Corinne Hubinont and colleagues write that they “did not have access to the patient’s gynaecological records throughout the pregnancy,” but that “Recently, we had the opportunity to read the patient’s notes,” which include a progesterone measurement “omitted by Donnez and colleagues:”

In light of these hormonal data, we cannot conclude whether the pregnancy resulted from the transplant or from the in-situ ovary. This conclusion accords with that of Oktay and Tilly, who suggested that “Donnez and colleagues fall short of providing conclusive evidence for the first pregnancy after this procedure”. Therefore we would like to retract our correspondence about this case report, since we want to ensure the integrity of the literature.

Donnez et al respond:

Since 2003, Corinne Hubinont and colleagues have had open access to all documents and protocols archived in the clinical database (Medical Explorer) at our university.

They also note that

We also clearly mentioned that a small corpus luteum was visible on the left ovary, and this of course implies the presence of progesterone.

The authors then, in some detail,

reiterate the numerous lines of evidence that lend support to our assertion that the origin of the pregnancy was the auto transplanted cryopreserved tissue.

Donnez et al note that “This is the 20th livebirth after cryopreserved ovarian tissue transplantation worldwide since 2004,” including four in their own department,

clearly showing that ovarian tissue cryopreservation should be regarded as an effective procedure that should be off ered to all young women diagnosed with cancer, in conjunction with other existing options for fertility preservation such as immature oocyte retrieval, in-vitro maturation of oocytes, oocyte vitrifi cation, and embryo cryopreservation.

Just as Human Reproduction editor Andre Van Steirteghem did in his journal in response to letters from Donnez and his colleagues disputing evidence, Lancet editors Stuart Spencer and Richard Horton offer their take (Spencer tells Retraction Watch that the journal has not formally retracted the Hubinont et al letter.):

In 2004, The Lancet published a report by Donnez and colleagues of the fi rst livebirth after orthotopic cryopreserved ovary transplantation. What was not known to The Lancet at the time was that the work had been the subject of an internal enquiry within the University of Louvain, Brussels, Belgium, and rejection by another journal.

Subsequently, The Lancet published a letter from Hubinont and colleagues reporting more details of the course of the pregnancy. All but one of the authors of that letter now express their concerns about the validity of the conclusions reached by Donnez and colleagues and ask to retract their publication. One of the grounds for concern cited by Hubinont and colleagues for retraction is that review of the patient’s medical records does not allow one to conclude with certainty that the conception was not a result of ovulation from the in-situ ovary; this echoes a concern raised by Oktay and Tilly in a previous letter.3 Another concern is that full records were not available. The Lancet asked the University, through the Rector, Bruno Delvaux, about these concerns. Delvaux’s response was:

“UCL [Université catholique de Louvain] and the academic hospital CUSL [Cliniques universitaires Saint-Luc], confi rm that documents, protocols and analytical data were completely recorded at the time in 2003. The procedures are strictly defi ned. Once produced, the data are automatically transferred from the laboratory into Medical Explorer. This is the rule and this was verifi ed for the case. The records have been and are freely available to medical staff following the case.”